In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
Solvonis Therapeutics plc has completed synthesis of development candidates for its SVN-SDN-014 program, a novel series of serotonin, dopamine and noradrenaline modulators.
Psychedelic drugs continued to make regulatory and clinical headway, as non-believers converted to believers in the category once regarded with skepticism, to say the least.
The endocannabinoid system is involved in pain perception, cognition and mood regulation among other functions. The dysregulation in synthesis and degradation of endocannabinoids results in anxiety, depression or degenerative diseases.
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
