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news.King Pharmaceuticals, a vertically integrated pharmaceutical company, has initiated the Phase II clinical trial program evaluating the efficacy and safety of T-62, an oral tablet formulation, the company's investigational drug for the treatment of neuropathic pain.
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The Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain.
The study is expected to enroll approximately 130 patients in up to 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient is expected to complete a seven-day screening period, a 28-day treatment period, and a 14-day post-treatment period.
Eric Carter, chief science officer of King Pharmaceuticals, said: T-62, a new chemical entity, is an adenosine A1 allosteric enhancer that increases the effectiveness of the body’s endogenous adenosine to treat neuropathic pain. The successful development of this product would address a substantial unmet medical need for more effective medicines to treat this serious condition.
Earlier this month, King Pharmaceuticals a new drug application for CorVue (binodenoson) for injection to the US Food & Drug Administration. CorVue is a cardiac pharmacologic stress SPECT (single-photon-emission computed tomographic) imaging agent intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test.