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.