Will the FDA Approve Alexza's Adasuve?

Will the Food and Drug Administration approve Alexza Pharmaceuticals' (Nasdaq: ALXA  ) Adasuve? The question could be rephrased, "Will the FDA buy Alexza's new risk evaluation and mitigation strategy?" Because that's basically what the approval comes down to.

There's little doubt about the efficacy of Adasuve, an inhaled antipsychotic. The FDA advisory panel voted 17 to 1 that the drug was effective as a treatment for agitation against schizophrenia and bipolar mania. Adasuve was only compared to placebo, which could make it tough to compete with injectable forms of Eli Lilly's (NYSE: LLY  ) Zyprexa, Bristol-Myers Squibb's (NYSE: BMY  ) Abilify and Pfizer's (NYSE: PFE  ) Geodon, but the lack of a head-to-head trial shouldn't keep Adasuve from getting approved.

Adasuve's stumbling block is with safety. The drug is inhaled and seems to decrease lung function in patients taking the drug. It's not a major problem for the average patient, but may be a problem for patients with lung conditions such as asthma or chronic obstructive pulmonary disorder.

Enter the "risk evaluation and mitigation strategy," or REMS. The proposal calls for patients to be prescreened to ensure that they don't have lung issues and then watched afterward to ensure that no issues arise later. Facilities will need to be prepared to deal with patients who have respiratory issues.

Alexza proposed one REMS, and the FDA proposed another. The advisory panel liked the agency's tougher version better. The panel voted 9 to 8, with one abstention, that the drug should be approved with the FDA's suggested REMS.

Alexza saw the writing on the wall -- literally, as the advisory panel votes were displayed on a screen on the wall at the meeting -- and submitted a new REMS, which delayed the FDA decision by three months to tomorrow, assuming the agency meets its Prescription Drug User Fee Act goal.

As I said at the start, the question basically comes down to whether the FDA believes the REMS can protect patients from lung issues. My guess is that the agency rejects Adasuve, because a 9-to-8 vote isn't exactly a resounding vote of confidence, and there are other options for treating agitation in patients with schizophrenia and bipolar mania.

But that's just a guess based on what we know; getting into the FDA's heads on this one is a little tough. Let us know what you think in the poll below and fill in your reasoning in the comments box below.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Pfizer. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.


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  • Report this Comment On May 03, 2012, at 3:03 PM, thesunbird76 wrote:

    Just like Motley Fools to incite fear. You people are probably puppets working for the hedge funds hoping to drive the price of ALXA down by writing a misleading article. Good always in the end over comes evil.

  • Report this Comment On May 03, 2012, at 3:08 PM, pappacritique wrote:

    Considering this was a re-submission and the vote was so close--chances are it will be approved. There will be considerable hurdles to clear in terms of mitigation with the slew of negative side effects that come with any newly marketed drug. It's a close call. No risk, no reward, right?

  • Report this Comment On May 03, 2012, at 6:33 PM, Momentum21 wrote:

    sunbird - ALXA needs no help driving its stock price down...

    I thought it was a good small bet after it sold off late in the day but I was wrong. Probably a leak that should have been an red flag I guess. : (

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