The FDA has approved a new kind of drug to treat schizophrenia that touts fewer side effects than current options, after seeing encouraging results from trials by the drug’s maker. The FDA approved Bristol Myers Squibb’s new treatment, Cobenfy, in September, after getting positive results from two of the company’s five-week trials of the drug.
Now, the results of two yearlong studies have been released as well. While most of the participants who signed up for the trials dropped out because of side effects — which doctors say is common for schizophrenia drug trials — those who stayed in showed significant improvement.
One study focused on severely ill patients while the other looked at people who were considered more stable over the course of a year.
Among the severely ill patients, 78% dropped out of the study, leaving only 35 participants.
Just over half of participants (51%) in the more stable group study didn’t finish the trial, leaving 283 people who did take the drug for a full year.
Of those in the severely ill group who did finish the trial, 69% showed meaningful improvement in their symptoms after a year. Nearly a third (30%) of those in the more stable group improved as well.
Honored to have our novel treatment for #schizophrenia in adults recognized on the @TIME #TIMEBestInventions of 2024 list. https://t.co/1gR8HUoeh5 https://t.co/7QYS9nlhZY
— Bristol Myers Squibb (@bmsnews) October 30, 2024
This drug could represent a breakthrough in treating schizophrenia, which has been notoriously hard to consistently treat because many people feel the side effects outweigh the benefits.
The new drug works differently from traditional antipsychotics. Instead of blocking dopamine receptors, Cobenfy’s main ingredient targets a different receptor that indirectly blocks dopamine release.
One of its other main ingredients blocks some of the common side effects that come with schizophrenia meds, like nausea, vomiting and indigestion, and has been associated with slight weight loss instead of weight gain.
Still, it’s not clear what side effects led participants to drop out of the trial. One doctor who was not part of the study told The Associated Press that we’ll understand more as doctors start prescribing the drug.
Another concern is cost. Cobenfy goes for about $22,500 a year, compared to $540 for a generic antipsychotic. Some doctors are concerned insurance companies will require schizophrenia patients to try other, less expensive drugs before they can move on to Cobenfy.
Currently, there is one cheaper generic that is widely considered one of the best treatments for schizophrenia, clozapine. However, it’s not used as often because it requires blood testing to watch for the risk of severe neutropenia, a condition that causes the body to have a low number of white blood cells which are essential for fighting infections.
Patients have reported relapses in symptoms when that medication was delayed over testing requirements.
