From Med City News. “A Bristol Myers Squibb drug whose landmark FDA approval introduced the first novel mechanism for treating schizophrenia in decades has failed a pivotal test intended to support expanding its use, a disappointing result that puts a big dent in the commercial prospects for the projected blockbuster product.
The Phase 3 test evaluated the drug, Cobenfy, as an adjunct to atypical antipsychotics in adults whose schizophrenia symptoms were inadequately controlled by these standard-of-care drugs. In preliminary results released after Tuesday’s market close, BMS said Cobenfy achieved a numerical change in score according to a scale used to assess symptoms in psychotic disorders, but this change measured at week 6 was not enough to be statistically significant compared to a placebo. BMS said Cobenfy’s safety profile was consistent with prior tests of the drug.
Last September, the FDA approved Cobenfy as a standalone treatment for schizophrenia in adults, marking the first regulatory nod in the emerging class of muscarinic receptor-targeting drugs. The drug was projected to become a blockbuster seller, and BMS has been conducting additional clinical testing to support potential expansion of use of the product. Besides the pivotal test of Cobenfy as an add-on therapy in schizophrenia, BMS is running a clinical trial evaluating the drug as a treatment for Alzheimer’s-associated psychosis.”
