Post-traumatic stress disorder (PTSD) is a condition with limited effective therapeutic options to date, where 5-HT2A receptor agonists show promise for enhancing cortical plasticity in the brain and aiming in the processing of trauma. Engrail Therapeutics Inc. has presented data for their 5-HT2A agonist and dopamine D2/D3 receptor antagonist neuroplastogen ENX-205 for the potential treatment of PTSD.
Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
Synendos Therapeutics AG has delivered initial clinical data demonstrating the potential of its lead compound to selectively modulate the endocannabinoid system in the brain and to relieve anxiety symptoms without triggering a psychoactive response.
The first new U.S. FDA-approved therapeutic option for PTSD in more than 20 years will have to wait. A supplemental NDA seeking approval of Rexulti (brexpiprazole) combined with sertraline, filed by one of Japan’s biggest pharmas, Otsuka Pharmaceutical Co. Ltd., received a complete response letter (CRL) from the agency.
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.
