FDA Panel Gives the Nod to New Antipsychotic Drug

By: Fran Lowry

August 3, 2009 — The US Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee
has endorsed claims of efficacy and safety for the atypical antipsychotic drug asenapine (Saphris, Schering-Plough) for
the acute treatment of adults with schizophrenia and mania/mixed episodes of bipolar 1 disorder.

The drug is administered as a sublingual tablet and should provide a useful alternative for those patients who are
unable to swallow pills, Andrew Winokur, MD, PhD, from the University of Connecticut School of Medicine, Farmington, and a member of the expert panel, said.

The 14-member panel gave asenapine, a 5HT 2D2 antagonist, a relatively easy ride, as it voted unanimously in favor
of the drug’s efficacy and safety in the treatment of adults with mania and bipolar disorder. Only 2 panel members said
they were not convinced of asenapine’s safety and efficacy in the acute treatment of adult schizophrenia because 1 of
the 3 studies presented by the sponsor was negative for the new antipsychotic. In all, the manufacturer presented
efficacy data on more than 3000 patients and safety data — which extended more than 2 years in some cases — on
more than 4500 patients with schizophrenia or mania bipolar disorder.

Thomas P. Laughren, MD, director of the FDA’s division of psychiatry products, told the panel at the outset of the
hearing that although the FDA had not yet reached a final conclusion about the sponsor’s new drug application for
asenapine, “I can say that in general, we are in agreement with the sponsor that they have shown that the drug is
effective for these 2 claimed indications and that the safety profile for asenapine qualitatively looks very much like what we’ve seen for other atypical antipsychotics and in our view is acceptable.”

Panel members by and large agreed.

“I thought the safety was acceptable for an agent used for schizophrenia and it offered a variety of different side
effects, many of which were better than other agents in the class,” said Robert L. Hendren, DO, from the University of
California, San Francisco. “For bipolar and mania, it showed good efficacy and a novel, or interesting, safety profile that
would allow a greater range of possibilities for someone prescribing medications for people in this category.”

Ruth S. Day, PhD, from Duke University, Durham, North Carolina, said she thought the safety profile was comparable
with other drugs in the class, “but also a little bit better in some respects.”

The sole patient representative on the panel, Musa J. Mayer, MS, from New York City, said that to have a drug
available that does not cause significant weight gain “is really an important part of the armamentarium” in the treatment of mania and bipolar disorder.

However, she was less impressed with the efficacy and safety data in regard to schizophrenia. As 1 of the 2 naysayers,
Ms. Mayer told the hearing committee: “I believe that we get the kinds of drugs that we ask for and are willing to accept
and I think that if we demand more efficacy, we will find ourselves with better drugs. I’ve seen this work in cancer
treatment and I think it’s important to keep the standards high regardless of the difficulties of the research.”

Her remark prompted Gail W. Griffith, a writer and activist from Washington, DC, and the consumer representative on
the panel, to remark, “I sense that there is a concern that we aren’t setting the bar high enough with respect to this
class of drugs, or maybe all psychotropic drugs, and I suspect that these drugs are more maligned as a class of drugs,
as are the illnesses.”

The panel agreed that it is important for patients with these illnesses to have a variety of therapeutic options. Richard
P. Malone, MD, professor of psychiatry at Drexel University College of Medicine in Philadelphia, Pennsylvania, and
acting chair of the advisory committee, said asenapine “looks like a viable treatment option. Individual patients will have their individual responses both for efficacy and for safety, and asenapine will give them an opportunity for another option.”

Dr. Laughren also emphasized the importance of more treatment choices for patients with these disorders. “At the
present time, there are a number of other medications available for treating these conditions, but as you also know, it is important to have treatment options because not every patient responds to the available treatments, either because
they do not work or because they do not tolerate the drug, and so asenapine, if approved, would represent another
treatment option.”

Fran Lowry is a freelance writer for Medscape.

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