THE FUTURE OF MENTAL HEALTH DRUGS — Psychiatrists and some drug companies are bullish on novel drugs for intractable mental health conditions, like post-traumatic stress disorder and schizophrenia, even as the FDA denied one firm’s bid to pair psychedelic drug MDMA with talk therapy as a PTSD treatment. The agency is slated to decide by Sept. 26 whether to approve Bristol Myers Squibb’s KarXT, which could be the first new antipsychotic in decades to treat schizophrenia. Another biotech is waiting in the wings to bring a longer-acting version of the drug to market by the end of the decade. “I would describe this moment as a mini-boomlet in drug discovery because it’s been quiet for a really long time in terms of novel treatments,” Dr. Ken Duckworth, chief medical officer for the National Alliance on Mental Illness, said. The novel candidate: KarXT is thought to improve a range of schizophrenia symptoms. Most antipsychotics on the market address only “positive” symptoms, Duckworth said, or symptoms that patients shouldn’t experience, like auditory hallucinations. They’re also linked to side effects like weight gain and involuntary body tics. KarXT is expected to also treat the disease’s “negative” symptoms — social withdrawal, lack of motivation — or the absence of things that a patient should be able to do, he said. The gold-standard drug today for treatment-resistant schizophrenia is clozapine, a medication first trialed in the 1960s. Many patients partially respond to the therapy, Duckworth said, so they might not hear voices as loudly but still have trouble completing tasks. The drug is also subject to the FDA’s risk-mitigation protocol because it can cause abnormally low white blood cell count, with patients required to take blood tests before using it. However, the agency is considering changes to the program, with an advisory committee meeting scheduled for Nov. 19. The “prodrug” approach: Terran Biosciences is gearing up to innovate on KarXT, which patients would take twice daily if approved, by developing a once-daily pill and a long-acting injection. Terran is targeting a so-called prodrug — an inactive compound that metabolizes in the body and becomes an active drug — dubbed TerXT to compete with KarXT. The company got its prodrug patented earlier this year. CEO Dr. Sam Clark said he expects the compound to be eligible for an accelerated FDA approval pathway that could see a decision in five years — just as BMS’ marketing exclusivity for KarXT ends. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. So much for a quiet August! Are you planning to attend Thursday’s drug pricing event (more on that below)? Let us know and send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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