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Inhibitex reported results from a phase II trial of FV-100 for the treatment of shingles. This controlled, double-blind study enrolled 350 subjects, aged 50 years and older, across several US sites. The subjects were equally randomized to one of three treatment arms: 200 mg or 400 mg FV-100 administered once daily or 1,000 mg valacyclovir (standard of care) administered three times per day. Both doses of FV-100 showed improvement over valacyclovir in the primary endpoint, the reduction in the severity and duration of shingles-associated acute pain over the first 30 days post-infection (3% and 7%, difference). The the 200 mg and 400 mg FV-100 arms also resulted in a respective 4% and 14% reduction in the burden of shingles-associated pain over the first 90 days compared to the valacyclovir arm. In addition, 18% and 12% of subjects receiving 200 mg and 400 mg FV-100, respectively, developed PHN, compared to 20% of the valacyclovir-treated subjects, resulting in relative treatment differences of 12% and 39%, respectively. In the valacyclovir arm the time to lesion crusting was faster than the FV-100 arms; however, no differences were noted between the treatment arms on time to full lesion healing. The overall tolerability and side effect profile of both doses of FV-100 was comparable to valacyclovir.
Epiphany BioSciences released positive results from a phase IIb trial of valomaciclovir for the treatment of Herpes Zoster (shingles). This double-blind, non-inferiority study enrolled 373 subjects who were randomized into to receive 1, 2 or 3 grams of once-daily valomaciclovir or standard of care (valacyclovir: 1 gram, three times per day). The primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash. The two highest doses of once-daily valomaciclovir met the primary endpoint, and the highest dose demonstrated superiority to valacyclovir (p<0.007). Valomaciclovir was also non-inferior to valacyclovir in the secondary endpoints of time to complete pain resolution, time to rash resolution and time to cessation of new lesion formation. There were no differences in significant adverse events between the treatment arms.
NeurogesX reported positive results from a phase III trial of Transacin for the treatment of post-herpetic neuralgia. This trial enrolled 402 subjects who were randomized to receive a single, one-hour treatment with Transacin or a matching, low-concentration capsaicin control patch. Pain intensity was recorded daily by the subjects for 12 weeks, using the Numeric Pain Rating Scale. The primary endpoint of the trial was met, with subjects in the treatment group reporting a statistically significant reduction in pain after a one hour infusion with Transacin (p=0.001). This reduction in pain was noted during the first week following treatment (p=0.04) and was maintained throughout the 12-week study period. NeurogesX plans to submit a MAA to the EMEA in early 2007 and a NDA to the FDA in mid-2008.
Depomed has issued positive results of a pair of trials of gabapentin GR for the treatment of post-herpetic neuralgia (PHN). These open-label studies enrolled 33 healthy male volunteers in a pharmacokinetic study and a dose proportionality study. In the pharmacokinetic study, 15 subjects received 600 mg of either gabapentin GR or an immediate release formulation of the drug with a standardized meal, and trial data indicated similar single-dose bioavailability. In the dose-proportionality study, 19 subjects received escalating single doses of gabapentin GR (600 mg, 1200 mg, 1800 mg or 2400 mg). Trial data indicated a nearly-linear 24 hour absorption profile for the four doses (35,698 ng*hr/ml, 63,209 ng*hr/ml, 90,893 ng*hr/ml, and 108,572 ng*hr/ml, respectively). At that time, Depomed's phase III trial of the drug for the treatment of PHN was ongoing.
Merck and Oka has reported positive results of a phase III trial of Zostavax, their live attenuated Herpes zoster vaccine, for the prevention of shingles. A different formulation of the vaccine is currently approved to for the prevention of chicken pox infections in children under the trade name Varivax. Study data met their primary endpoint, producing a significant reduction the incidence, severity and duration of pain and discomfort associated with shingles by 61.1%, vs. placebo (p<0.001). Furthermore, reductions were also noted in rate of post-herpetic neuralgia (66.5% reduction; p<0.001), and overall incidence of shingles (51.3% reduction; p<0.001). This randomized, double-blind, placebo-controlled study enrolled 38,546 adults with no history of shingles, who received a single-dose of the vaccine or placebo and were then followed for 3.12 years. These data supported the companies' recently filed BLA and MAA applications.
XenoPort has reported positive results of a phase IIa trial of their transported gabapentin prodrug XP13512, for the treatment of post-herpetic neuralgia (PHN). Study data indicated that the drug produced a statistically significant reduction in pain severity over the final 7 days of treatment vs. placebo (p=0.032), the primary endpoint. The drug also produced significant improvement in secondary endpoints, including symptom severity score on the Short-Form McGill Pain Questionnaire, sleep interference, total pain score at the end of treatment, and Patient and Investigator Global Impression of Change. Pharmacokinetic analysis indicated that the prodrug produced a higher absolute steady-state plasma concentration than gabapentin alone, despite a 33% reduction in total equivalent gabapentin dose. This double-blind, placebo-controlled, multicenter study enrolled 101 PHN patients across 18 US sites, who all received 7 days of treatment with 600 mg. thrice daily gabapentin, followed by randomization to either 1,200 mg twice daily XP13512 or placebo for 14 days.
Renovis announced the results of a phase II study of REN-1654, their investigational TNF-alpha release inhibitor for the treatment of post-herpetic neuralgia (PHN). Study data failed to meet their primary efficacy endpoint, with mean reduction in daily spontaneous pain severity ratings at three weeks of -0.60 points for the low dose drug group, -0.57 for the high dose drug group, and -0.90 for the placebo group (no significant difference between values). The drug was generally well tolerated, and incidence of serious adverse events was similar between the drug and placebo. This double-blinded, placebo-controlled, multi-center study enrolled 94 patients with a history of herpes zoster (shingles) followed by persistent pain due to PHN. Following a 1-week washout/baseline period, subjects were randomized to receive one of two doses of REN-1654 (30 mg or 100 mg) or placebo once daily for 21 days. Renovis announced plans to discontinue development of the drug for PHN, but stated that these data would not affect an ongoing phase II trial of the drug for the treatment of sciatica.
NeurogesX reported positive results from a phase II trial investigating NGX-4010, a capsaicin-containing dermal patch for the treatment of postherpetic neuralgia (post-shingles pain). Results showed that 42% of subjects in the active group experienced more than a 33 % pain decrease compared to 8 % in the control group. Treatment consisted of a topical non-prescription anesthetic for one hour, followed by a one-hour patch application. Overall drug tolerability was good with no safety concerns identified. The control group received a low-concentration capsaicin patch. Subjects recorded pain intensity twice daily on an 11-point numerical scale. The double blind, randomized controlled, multi-center study evaluated the tolerability, safety and efficacy of NGX-401 in the treatment of postherpetic neuralgia. The study enrolled 44 subjects for four weeks at nine sites in the U.S.