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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.