Motley Fool Screws Up, Risperdal Injection Not Approved For Bipolar Disorder

J&J announced late today that its long-acting injectable Risperdal CONSTA, an atypical antipsychotic, was not approved by the FDA, but that the agency had instead sent a letter to the company requesting additional information about the drug. The company is seeking approval for the injectable for frequently-relapsing bipolar disorder (whatever the hell that is exactly) and also for bipolar disorder in general. It's not clear what information the agnecy is seeking, as it's up to J&J to release the FDA's letter and all the company is saying is that the agency didn't request extra studies.

Earlier in the day, The Motley Fool investment news site had essentially predicted smooth sailing for the drug through the approval process. "Candy and Roses from the FDA" was the site's title for its reporting:

"Johnson & Johnson's (NYSE: JNJ) Risperdal Consta is already approved [for schizophrenia], but this month the company should have an opportunity to expand sales of the antipsychotic. The long-lasting version of Risperdal, which was developed using technology from Alkermes (Nasdaq: ALKS), is being reviewed as a treatment for frequently relapsing bipolar disorder.

"Patients in this subset make up only 10% to 20% of patients with bipolar disorder, but approval would be just the first step for J&J. The company has already submitted a marketing application for general bipolar disorder, which is scheduled to be acted on by the FDA later this year.

"An approval seems pretty likely. The drug’s short-acting older sibling, Risperdal, is already approved to treat bipolar disorder, and unlike Eli Lilly's (NYSE: LLY) long-acting version of its antipsychotic, Zyprexa, which the FDA has been reluctant to approve, Risperdal Consta is already approved, making safety issues less likely."

Looks like the fool was motley indeed.

As for the claim that the potential market for this drug would be 10 percent to 20 percent of people diagnosed with bipolar disorder, that doesn't even pass the smell test. Somewhere between 6 million to 9 million American adults are diagnosed with bipolar disorder and from what I know there aren't anything close to 600,000 to 1.8 million people with the disorder who need anything approaching an injectable. Perhaps that prevalence number comes from a study that was done in a very tough public health hospital population, but it sure as hell doesn't add up with the reality I know of.