People being treated for schizophrenia and bipolar disorder soon may have another treatment option. Last month, Schering-Plough moved a step closer to FDA approval for its drug asenapine, which it would market as Saphris.
In February, Schering-Plough responded to an FDA request for more information, including additional data from clinical trials on more than 3,000 patients with schizophrenia and bipolar disorder. The company stresses that the FDA has not requested any further clinical trials.
“Another positive step forward is that [the FDA] approved the draft labeling for both indications: schizophrenia and bipolar 1 disorder,” notes Robert Consalvo, director of global product communications and advocacy relations for Schering-Plough, which recently announced a merger with
Merck & Co. Asenapine is a second-generation or “atypical” antipsychotic. Others include:
- aripiprazole (Abilify)
- clozapine (Clozaril)
- olanzapine (Zyprexa)
- paliperidone (Invega)
- quetiapine (Seroquel)
- risperidone (Risperdal)
- ziprasidone (Geodon)
The question physicians, patients, and payers are likely to have is whether asenapine offers any clinical advantage over the drugs already on the market.
Consalvo says that in head-to-head comparisons with similar atypicals, asenapine demonstrates greater tolerability.
“Basically these drugs have tended to fall into two baskets,” he says. One group is potent but has side effects such as weight gain or blood sugar issues, while others are better tolerated but not as effective, Consalvo explains. “We see asenapine combining the potency with that acceptable metabolic profile.”
If that’s the case, then asenapine would make a contribution to the field, notes Jeffrey Lieberman, MD, the Lawrence E. Kolb Chairman of Psychiatry at Columbia University’s College of Physicians and Surgeons and director of the New York State Psychiatric Institute. “But the data that have emerged so far haven’t shown that,” he says. “The studies haven’t shown that it provides any unique therapeutic advantage. The main contribution is that clinicians and patients will have yet another choice.”
Dr. Lieberman added that asenapine would join an already crowded market of atypicals.
Such concerns often greet new drugs in an existing class. If the FDA approves asenapine, it ultimately will be up to clinicians and patients to determine its value.
David Raths is a freelance writer.