Clinical Trials Resource Center


May 16, 2016

TherapeuticsMD released results of a phase III trial of TX-004HR moderate-to-severe vaginal pain during sexual intercourse (dyspareunia). The randomized, double-blind, placebo-controlled, multicenter, study dosed TX-004HR at 25mcg, 10mcg and 4mcg doses in postmenopausal women with a moderate-to-severe dyspareunia. At week 12, all TX-004HR doses compared with placebo significantly improved the four co-primary endpoints, including vaginal superficial cells, vaginal parabasal cells, vaginal pH and the severity of dyspareunia (all p<0.00001 except dyspareunia at 4mcg p=0.0149). Moreover, the changes in cytology, pH and dyspareunia were significant at all intermediate time points (weeks two, six and eight). The Rejoice Trial secondary endpoint result for vaginal dryness was also statistically significant for all three doses evaluated, as moderate-to-severe vaginal dryness was reported by 93% of patients at baseline, and was significantly improved (p<0.02) for all doses at weeks two, six, eight and 12 (except the 4mcg dose at week two). A post-study patient questionnaire showed TX-004HR had high patient acceptability and satisfaction. TX-004HR was well-tolerated; the most frequently reported treatment-emergent adverse events (AEs) were headache, vaginal discharge, nasopharyngitis and vulvovaginal pruritus. Vaginal discharge and vulvovaginal pruritus were numerically higher in the placebo group. No clinically significant differences in AEs between treatment and placebo groups were observed. TherapeuticsMD plans to use the Rejoice Trial data as the basis for an NDA to the FDA for TX-004HR.

February 22, 2016

Neurocrine Biosciences issued results of the second of two replicate pivotal phase III clinical trials evaluating Elagolix in premenopausal women who suffer pain from endometriosis. The first phase III trial (M12-665) was a 24-week, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Elagolix in 872 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain. It was conducted at approximately 160 sites in the U.S., Puerto Rico and Canada. The second phase III trial (M12-671) employed the same design as the first phase III pivotal trial, but was multinational and included 815 women with moderate-to-severe endometriosis-associated pain across 226 sites in 13 countries. Trial results show that after six months of continuous treatment, both doses of Elagolix (150mg once daily and 200mg twice daily) met the study’s co-primary endpoints. Elagolix reduced scores of menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis, at month three and month six, as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of Elagolix in this study was consistent with observations from the first phase III pivotal study and prior Elagolix studies. Among the most common treatment-emergent adverse events (TEAEs) were hot flush, headache and nausea. As anticipated by the mechanism of action, some AEs, such as hot flush, other hypoestrogenic TEAEs and changes in bone mineral density (BMD) were dose-dependent. Overall discontinuation rates were similar across treatment groups (25.3%, 21.2% and 19.7% for placebo, 150mg once daily and 200mg twice daily, respectively); discontinuations specifically due to TEAEs were 6.1%, 4.4% and 10% for placebo, 150mg once daily and 200mg twice daily, respectively. AbbVie will complete the clinical database in anticipation of a New Drug Application submission for endometriosis in 2017.

November 23, 2015

AcelRx Pharmaceuticals has released results in a phase III study of Zalviso (sufentanil sublingual tablet system 15mcg) for the treatment of faster onset of pain relief in obese (BMI 30kg/m2) post-surgical patients. Patients who self-administered Zalviso experienced statistically significantly improved pain relief when compared to self-administered IV morphine as measured by pain intensity difference to baseline (PID). Significant differences in PID were observed as early as 45 minutes after the first dose (p<0.05), a trend that continued until six hours after the initial dose (p<0.001), after which time PID scores equilibrated between the two groups. Results of the subgroup analysis presented by AcelRx also show that obese patients who administered Zalviso experienced statistically fewer adverse events than did those receiving intravenous patient-controlled analgesia morphine. While overall adverse event rates were comparable, incidence rates of anemia, leukocytosis (increase in white blood cells), vomiting, hypoalbuminemia (decrease in albumin levels), hyponatremia (decrease in sodium levels), urinary retention and pruritus (itching) were all significantly lower in the Zalviso arm compared to the morphine arm (p≤0.05).

November 9, 2015

Elite Pharmaceuticals has reported results of a phase III trial of opioid abuse-deterrent candidate ELI-200 for the treatment of moderate to severe pain. It was a multicenter, randomized, multiple-dose, double blind, placebo-controlled and parallel group study. The trial randomized 163 patients. The pivotal trial met its primary endpoint (p=0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial. Elite intends to submit an NDA to the FDA for abuse-deterrent ELI-200 by year-end.

September 14, 2015

Collegium Pharmaceutical reported results of a phase III trial of Xtampza ER (oxycodone extended-release capsules) for moderate-to-severe chronic low back pain. The multicenter, randomized, double-blind, enriched enrollment, randomized withdrawal, placebo-controlled study met its primary endpoint, which showed a statistically significant difference in average pain intensity from Randomization Baseline to week 12 between the Xtampza ER and placebo groups (p<0.0001). All sensitivity analyses of the primary endpoint also were statistically significant. Xtampza ER had an adverse event profile consistent with other opioids, was well-tolerated, and no new safety concerns were identified. The company is seeking FDA approval for Xtampza ER.

Vernalis released results of a phase II study of V158866 for neuropathic pain as a result of spinal cord injury. In the randomized, double-blind, placebo-controlled, two-period cross-over study, although dosing of V158866 resulted in elevated endocannabinoid levels, on an intent-to-treat basis the study failed to meet its pain reduction primary endpoint. Treatment with V158866 did show a trend toward efficacy on a per protocol basis (p=0.054) and was generally well-tolerated.

July 13, 2015

AcelRx Pharmaceuticals reported results of a phase III study of Zalviso for the treatment of moderate-to-severe postoperative pain in patients following major joint replacement surgery. The study met its primary endpoint, demonstrating that Zalviso was significantly better at managing pain over 48 hours as measured by Summed Pain Intensity Difference to Baseline (SPID- 48), than placebo (p<0.001). Zalviso-treated patients had pain relief scores superior to placebo-treated patients within 45 minutes of study initiation. Reports of treatment-related adverse events were similar between the two groups, with the exception of nausea and itching, which were higher in the Zalviso group. It was noted that fewer Zalviso patients dropped out of the study due to inadequate analgesia compared to placebo (14% v. 48%; p<0.001) and used approximately half as much rescue morphine over the duration of the trial (2.3 doses v. 4 doses). As a secondary endpoint, a validated ease-of-care questionnaire was administered to patients and healthcare providers. Both groups gave Zalviso a total overall rating above four on a scale of zero to five. Zalviso is currently under review by the FDA.

January 26, 2015

Mesoblast has issued positive results of a phase II program of MPC-06-ID for the treatment of chronic low back pain due to degenerative disc disease. In the randomized, placebo-controlled trial of 100 patients, a single injection of Mesoblast’s allogeneic investigational mesenchymal precursor cell (MPC) product, MPC-06-ID, was welltolerated. A single injection of 6 million MPCs induced substantial and sustained pain relief over 24 months. At 12 and 24 months, 46% and 48% of MPC-06-ID-treated patients achieved minimal or no residual pain (VAS less than or equal to 20) compared with 13% and 13% of saline treated patients, p=0.042 and 0.093, respectively. In patients who received a single injection of six or 18 million MPCs, 44% and 42%, respectively, achieved the target composite endpoint of treatment success at both six and 12 months (50% reduction in pain, 15-point improvement in function and no further treatment intervention), compared with 13% of saline controls (p=0.006 and p=020). In patients who received six million MPCs and achieved the target composite endpoint of treatment success at both six and 12 months, 86% (11 of 13) maintained treatment success at 24 months (32% v. 11% saline controls, p=0.001). The phase III program for this indication has been initiated.

August 18, 2014

Collegium Pharmaceutical issued results of a phase III study of Oxycodone DETERx for the treatment of patients with moderate-to- severe chronic low back pain. The phase III study was a multicenter, double-blind, enriched-enrollment, randomized-withdrawal, placebo-controlled study of Oxycodone DETERx versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. Patients who achieved a stable and effective dose of Oxycodone DETERx during the open-label titration phase were randomized (n=389) into the 12-week, double-blind maintenance phase, in which they either were maintained on their current dose regimen of Oxycodone DETERx or were tapered to placebo. The primary efficacy endpoint of the study was the change in average pain intensity from baseline to week 12; pain was measured using an 11-point pain intensity numerical rating scale (PI-NRS). The study met the primary efficacy endpoint, showing patients with chronic low back pain treated with Oxycodone DETERx experienced a statistically significant reduction in pain compared with placebo (p< 0.0001). The company is positioned to file an NDA with the FDA for Oxycodone DETERx by the end of 2014.

June 16, 2014

OptiNose reported results of a trial comparing AVP-825 to sumatriptan tablets for migraine pain during the first 30 minutes after treatment. The multi-center, randomized, double-blind, double-dummy crossover, multi-attack study enrolled 275 migraine sufferers and treated a total of 1,531 acute migraines with either the only dose of AVP-825 (22mg) plus a placebo tablet or with a placebo delivered with an OptiNose Bi-Directional Breath Powered device, plus a high dose (100mg) sumatriptan tablet. The trial showed with AVP-825 treatment, early reduction in pain was achieved in more headaches than with oral sumatriptan. The primary endpoint showed during the first 30 minutes, headache pain intensity was statistically significantly lower with AVP-825 treatment (p<0.0001). In addition, the trial achieved statistical significance for relevant secondary measures of Pain Relief and Pain Freedom as early as 15 minutes and at all of the following early time points measured (30, 45, 60, 90) before 120 minutes. Less than 2% of subjects experienced an adverse event leading to treatment discontinuation with use of either medication and there were no serious adverse events. An NDA for AVP-825 was filed earlier this year, and the Prescription Drug User Fee Act (PDUFA) V goal date is Nov. 26.

March 10, 2014

Sinovac Biotech reported results of phase III trials of Enterovirus 71 (EV71)vaccine for the treatment of foot and mouth disease (HFMD), or herpangina. The phase III clinical trial on 10,077 healthy infants and young children in China (six to 35 months of age) was a randomized, double-blind, placebocontrolled, multicenter trial method. The subjects were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either Sinovac’s EV71 vaccine or placebo, 28 days apart for 12 months. Clinical results showed the efficacy of the vaccine was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. Sinovac’s vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities. Regulatory approval is pending.

November 11, 2013

Cara Therapeutics issued results of a phase II trial of I.V. CR845 for the treatment of acute pain. The randomized, doubleblind, placebo-controlled trial of I.V. CR845 (0.005mg/kg/dose) enrolled 51 women and men undergoing a primary unilateral first-metatarsal bunionectomy surgery in the U.S. Repeat dosing of I.V. CR845 over 48 hours post-surgery provided statistically greater pain reduction than placebo at both the 24- and 48-hour time points following initiation of treatment, as assessed using the FDA recommended endpoint, the Summed Pain Intensity Difference (SPID). The I.V. CR845 treatment arm met the trial’s primary endpoint of a statistically significant reduction in pain intensity, as measured by the SPID score, over the initial 24-hour time period (SPID0-24; p<0.05) compared to placebo. The I.V. CR845 treatment arm also met the secondary endpoint of a statistical reduction in pain intensity over the entire 48-hour dosing period (SPID0-48; p<0.025). In addition, I.V. CR845 treatment resulted in a statistically significant reduction in the incidence of opioid-related adverse events of nausea and vomiting (by 60% and 80%, respectively; p<0.05) compared to placebo during the 48-hour treatment period.

November 4, 2013

AstraZeneca released results of a phase III trial of naloxegol for the treatment of non-cancer pain and opioid-induced constipation (OIC). The study enrolled 844 patients, provided a once-daily 25mg dose of naloxegol and lasted 52 weeks, comparing naloxegol (n=534) to usual care (n=270). Usual care was defined as the investigator’s choice of an existing laxative treatment regimen for OIC. Most naloxegol-emergent gastrointestinal adverse events (AEs) occurred early in treatment and were transient with nine patients (1.6%) discontinuing naloxegol due to abdominal pain. Most common treatment-emergent AEs occurring more often with naloxegol v. usual care were abdominal pain (17.8% v. 3.3%), diarrhoea (12.9% v. 5.9%), nausea (9.4% v. 4.1%), headache (9.0% v. 4.8%) and flatulence (6.9% v. 1.1%). Pain scores and opioid doses were comparable between treatment groups and were stable throughout the study. There were two opioid withdrawal AEs reported in patients taking naloxegol (both were deemed unrelated to treatment with naloxegol).

August 12, 2013

Pharmanest released results of a phase II study of SHACT for the treatment of pain in connection with intrauterine device insertion. SHACT is a product based on a formulation of lidocaine, an anesthetic, and a proprietary application device developed to simplify topical application in the cervix and uterus. The randomized, double-blind trial involving 218 women between ages 18 and 45 showed women receiving SHACT during IUD insertion experienced a more than 30% reduction in pain, measured on a visual analogue scale, compared to patients who received placebo. This effect was statistically significant (p < 0.0001). Patients who received SHACT also experienced less discomfort (p < 0.05) than women who received placebo. Women who received SHACT reported similar adverse events, in terms of type and frequency, as women who received placebo treatment.

July 8, 2013

Nektar Therapeutics issued results from a randomized, double-blind, placebo- and active-controlled, five-way crossover trial of NKTR-181 for the treatment of moderate-to-severe chronic pain. The trial compared three doses of NKTR-181 oral solution (100mg, 200mg, and 400mg) to the effects of 40mg of oxycodone oral solution and placebo. Participants were healthy adults (N=42) who were not currently physically opioid-dependent but had used opioids to attain non-medical effects on at least 10 occasions during the past year and at least once in the 12 weeks before the study. All oral doses of NKTR-181 scored similar to placebo in a Drug Effects Questionnaire (DEQ) assessing the treatment’s effect on how “high” the subject felt (on a scale of 0 to 100). Maximum mean DEQ scores were 14, 14 and 23 for 100mg, 200mg tablet and 400mg, respectively, with p-values < 0.0001 as compared to oxycodone. Placebo achieved a maximum mean score of nine. NKTR-181 is currently being evaluated in phase II development as a twice-daily oral tablet.

April 22, 2013

Iroko Pharmaceuticals issued results from a phase III trial of lower dose submicron indomethacin for the treatment of post surgical acute pain. This multi-center, double-blind, placebo- and active- controlled study enrolled 462 patients with moderate to severe pain following bunionectomy surgery. Subjects received 40mg submicron indomethacin three times daily or twice daily, 20mg submicron indomethacin three times daily, 400mg loading dose of celecoxib plus 200mg twice daily, or placebo. Statistically significant overall decreases in pain intensity were demonstrated for 40mg submicron indomethacin three times daily (509.6, p<0.001), 40mg submicron indomethacin twice daily (328.0, p=0.046), 20mg submicron indomethacin three times daily (380.5, p=0.017), compared with placebo (67.8). Although there was some evidence of analgesia for celecoxib (279.4), it did not achieve statistical significance compared with placebo. Some evidence of pain control was observed as early as 30 minutes in the 40mg submicron indomethacin three times daily (2.9) and 40mg submicron indomethacin twice daily (2.6) groups compared with placebo (0.2). The drug was well tolerated. The most frequent adverse events were similar across treatment groups and included nausea, post-procedural edema, dizziness and headache.

March 18, 2013

AcelRx Pharmaceuticals released results from a phase III trial of sublingual Sufentanil NanoTab PCA System for the treatment of acute post-operative pain. This randomized, double-blind, placebo-controlled study enrolled 178 patients with acute post-operative pain following major open abdominal surgery. Subjects received either sufentanil or placebo for 48 to 72 hours, delivered as needed using the NanoTab PCA System. Results demonstrated patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 (Summed Pain Intensity Difference over 48 hours), 105.6, during the study period than placebo-treated patients, 55.6, (p=0.001). Secondary endpoint data also showed 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004 respectively). The drug was well tolerated. The most frequent adverse events were comparable between treatment groups and included nausea, fever, vomiting, itching, oxygen saturation decrease and hypertension. Currently, AcelRx Pharmacuticals’ second phase III, double-blind, placebo-controlled study of the Sufentanil NanoTab PCA System is underway. Based on favorable results, AcelRx plans to file a New Drug Application in the third quarter of 2013.

March 11, 2013

AcelRx issued results from a phase III trial of sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) for the treatment of acute post-operative pain. This randomized, double-blind, placebo-controlled trial enrolled 178 adults who were treated for post-operative pain immediately following major abdominal surgery. The subjects were treated for a minimum of 48 hours and up to 72 hours with either sufentanil or placebo. Both treatments were delivered by the each subject, as needed, using the NanoTab System with a 20-minute lock-out period. Both groups could receive up to 2mg morphine intravenously per hour as a rescue medication. The primary endpoint evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48). The sufentanil NanoTabs arm reached a significantly greater SPID-48 during the study period than placebo arm (p=0.001). In addition, 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated arm than in the placebo-treated arm (p<0.001 and p=0.004, respectively).

November 28, 2012

AcelRx Pharmaceuticals reported results from a phase III trial of sublingual ARX-01 (Sufentanil NanoTab PCA System) for the treatment of post-operative pain. This randomized, open-label, parallel-group study enrolled 359 patients with acute post-operative pain immediately following major abdominal or orthopedic surgery. Subjects received (15mcg/dose) of the NanoTab System or 1mg/dose of PCA with morphine for a minimum of 48 hours and a maximum of 72 hours. Data demonstrated that the NanoTab System was non-inferior (p<0.001) to IV PCA morphine for the primary endpoint of PGA over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of “good” or “excellent” (78.5% versus 66.1% respectively). In this study, the NanoTab System was found to be statistically superior to IV PCA morphine for the PGA endpoint (p=0.009). This statistically superior PGA was also seen at the 24-hour and 72-hour time points. Additionally, the percentage of patients rating the NanoTab System as “excellent” was higher than those rating IV PCA morphine as excellent (42.9% versus 30.6%, p=0.016). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% versus 8.3% respectively) or due to an adverse event (7.9% versus 11.1% respectively). The NanoTab System was well tolerated. AcelRx Pharmaceutical will complete two other phase III trials of the NanoTab System before submitting an NDA to the FDA.

September 10, 2012

NeurogesX reported results from a phase II trial of NGX-1998 for the treatment of postherpetic neuralgia (PHN). This multicenter, placebo-controlled, double-blind study enrolled patients who had experienced pain for at least six months following healing of a herpes zoster lesion and had a Mean Numeric Pain Rating Scale (NPRS) score between 4 and 9, inclusive. Subjects were divided into three arms: NGX-1998 capsaicin 20% solution, NGX-1998 capsaicin 10% solution or placebo. Results indicated that with a single, five-minute treatment with NGX-1998, subjects experienced pain relief for as long as three months. NGX-1998 showed a greater magnitude of response on the pain intensity scale correlating with the concentration of the formulation: 20%>10%>placebo. In addition, it was determined that no topical anesthetic pre-treatment was required for treatment with NGX-1998. The drug was well tolerated. Subjects experienced similar adverse events as those in the placebo arm. Based on these data, NeurogesX plans to enable a phase III trial in neuropathic pain.

August 20, 2012

Eli Lilly released results from a phase III trial of Forteo (teriparatide injection) compared to risedronate for the treatment of back pain. This randomized, double-blind, double-dummy, active-controlled study enrolled 710 postmenopausal women with at least one moderate or severe vertebral fracture thought to be the cause of back pain. Subjects received either Forteo 20mg/day or risedronate 35mg/week for 18 months. From baseline to six months, data showed no difference between Forteo (59.2%) and risedronate (57.4%) on the primary endpoint of at least a 30% reduction in worst back pain, as assessed by a numeric rating scale in each treatment group. However, there were statistically significant differences in favor of Forteo in some exploratory measures, including greater increases in bone mineral density (BMD) and fewer patients with new vertebral fractures. Furthermore, significantly fewer patients treated with Forteo experienced a worsening of average back pain between six and 18 months (23.6% versus 30.6% of risedronate-treated patients; p=0.04). Forteo was well tolerated. The most frequent adverse events were similar between both treatment groups. Eli Lilly did not note its plans for Forteo.

August 13, 2012

Array BioPharma released results from a phase II trial of ARRY-797 for the treatment of moderate to severe chronic knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). This randomized, placebo-controlled and active controlled study enrolled 157 patients with osteoarthritis. Subjects were divided (1:1:1) to receive ARRY-797, placebo or oxycodone ER while continuing their use of NSAIDs for four weeks. Data showed a statistically significant reduction in pain compared to placebo, as measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale. Patients receiving ARRY-797 experienced a mean reduction in the WOMAC pain subscale score at day 28 vs. baseline that was 0.8 greater than those receiving placebo (2.4 vs. 1.6; one-sided p=0.0247). ARRY-797 was well tolerated. The most frequent adverse events were dizziness, diarrhea and nausea. Array will begin seeking a partner to maximize the value of ARRY-797.

July 2, 2012

Iroko Pharmaceuticals issued results from a phase III trial of diclofenac for the treatment of post-surgery pain. The multi-center, randomized, double-blind, active- and placebo-controlled study enrolled 428 patients. Subjects received diclofenac 18mg or 35mg three times daily, or celecoxib 400mg on day one then 200mg twice a day, or placebo. The trial demonstrated significant improvement in pain relief as measured by the combined differences in pain intensity measured at intervals over 48 hours using a visual analog scale (VASSPID 48) in patients with acute pain. Pain relief scores were 524 for submicron particle diclofenac 35mg, 393 for 18mg, 390 for celecoxib and 0 for placebo. Subjects receiving submicron particle diclofenac capsules 35mg achieved pain relief (P=0.009) during the first four hours after initiating oral treatment (TOTPAR-4). The most frequent adverse events, comparable across treatment groups, were post-procedural swelling, nausea and headache. Based on these data, Iroko will pursue diclogenac as a low-dose alternative to NSAIDs.

October 26, 2009

Pacira released positive results from a phase III trial of Exparal (DepoBupivacaine) for the reduction of pain following bunionectomy. This US-based, randomized, double-blind, parallel-group, placebo controlled study enrolled 193 subjects undergoing first metatarsal osteotomy (bunionectomy). The subjects received a single administration of Exparel or placebo following surgery and evaluated for analgesic effect. The primary endpoint, reduction in area under the curve analysis (AUC) of the numeric rating scale scores, was reached with statistical significance in the subjects receiving Exparel compared to placebo over the first 24 hours following surgery (p≡0.0005). This difference continued to be statistically significant through 36 hours. The study also met secondary endpoints with statistical significance favoring Exparel for the percentage of subjects who were pain free through 8 hours and at 48 hours; the percentage of subjects who received no rescue medication through 24 hours; and the total amount of rescue required by 24 hours. Exparel was well tolerated, with the incidence of adverse events similar to placebo.

March 23, 2009

Durect reported positive results from a phase IIb trial of Transdur-sufentanil, a transdermal patch formulation of the opioid sufentanil. This open label, two-stage study enrolled 74 opioid-experienced subjects with non-malignant moderate to severe chronic pain. The study was designed to explore the conversion schedule for transitioning this population from current oral and transdermal opioid therapies to Transdur-Sufentanil. Following a baseline screening, the subjects were randomized into multiple titration regimens. After achieving an endpoint of adequate, stable pain control and an acceptable safety profile on Transdur-Sufentanil, they entered a 28-day continuous treatment maintenance period. This was followed by a seven day follow-up period to ensure that an adequate pain control regimen was re-established. Of the 74 initially enrolled subjects, 36 successfully entered the maintenance period. Two acceptable dose titration intervals achieved the desired analgesic effect and side-effect profile. The mean pain score during the maintenance period was 3.88 (on a ratings scale for pain intensity, with 0 being no pain) representing a reduction of approximately 19% from the mean baseline pain score of 4.78. Treatment was safe and well tolerated.

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