The designation Breakthrough Therapy is rarely used, having been granted to fewer than 300 drugs since it was established in 2012. It is designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
Clinical-stage pharmaceutical company Ensysce Biosciences, Inc. (NASDAQ:ENSC) is developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose. In a press release today, the firm announced the renewal of its collaboration with Quotient Sciences to undertake the study PF614-MPAR-102 to examine and evaluate the full commercial dose range of the PF614-MPAR drug product.
The Phase 1b study will evaluate opioid release following administration of PF614-MPAR at doses of 25 mg, 50 mg and 100 mg delivered twice daily for five days to verify both overdose protection and effective delivery of oxycodone. The study will apply the Quotient Sciences Translational Pharmaceutics® platform to manufacture and test the PF614-MPAR drug product to expedite the clinical study process. Shares were trading up at $0.70 in early afternoon trade.
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