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Trevena, Inc. reports developments as a biopharmaceutical company developing and commercializing medicines for central nervous system disorders. Its updates center on OLINVYK® (oliceridine) injection, a U.S.-approved intravenous opioid analgesic for acute pain in adults when alternatives are inadequate, and investigational CNS programs including TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for acute migraine, and TRV734 for maintenance treatment of opioid use disorder.
Recurring company news also covers financial results, cash resources, preclinical and formulation-study updates for TRV045, royalty-based financing arrangements tied to ex-U.S. OLINVYK economics, liability reductions, reverse stock splits, and trading-status changes following Nasdaq delisting and movement to OTC markets.
Trevena, Inc. (Nasdaq: TRVN) has received FDA approval for OLINVYK, addressing acute pain in adults requiring IV opioid analgesics. OLINVYK, a novel chemical entity, is set to launch in Q4 2020 pending controlled substance scheduling by the DEA. The drug's efficacy was established through extensive trials involving over 1,500 patients, demonstrating significant pain relief compared to placebo. With $54.8 million in cash reserves, Trevena is positioned for OLINVYK’s commercialization through 2021.
Trevena, Inc. (Nasdaq: TRVN) announced that its partner in China has received approval from the National Medical Products Administration to begin clinical trials for IV oliceridine, a pain management drug. This regulatory milestone supports Trevena's anticipated PDUFA date on August 7 for U.S. approval. The company expects milestone payments and a 10% royalty on net sales of oliceridine in China. Oliceridine is designed for managing moderate-to-severe acute pain and may have fewer side effects due to its selective action.
Trevena, Inc. (Nasdaq: TRVN) announced a collaboration with Imperial College London to evaluate TRV027, a novel AT1 receptor selective agonist, for treating acute lung injury in COVID-19 patients. This randomized, double-blind study will involve approximately 60 hospitalized patients aged 65 and older to assess TRV027's effect on health outcomes associated with ARDS. TRV027 has shown efficacy and safety in previous trials involving around 700 individuals. The study is supported by the British Heart Foundation Centre for Research Excellence Award.
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