Bipolar Today

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Adasuve is a technology designed to help bipolar and schizophrenic patients to reduce agitation rapidly. It delivers the antipsychotic drug, Loxaprine, into the patient’s lungs. This allows the drug to me administered extremely quickly, but with less invasiveness than any intravenous method. However, on the previous round of Adasuve’s attempt to get approval in 2009, the FDA expressed concern that Adasuve’s safety for the lungs and they did not get approval. They have reapplied, and they will receive a decision on December 12th. Adasuve is made by Alexza Pharma, Inc. and expects to make between $400 million and $500 million per year if this technology is approved. More information about Adasuve’s approval process can be found here.

Commentary

Adasuve is an interesting example of a medical technology that has been having trouble getting FDA approval. We tend to hear mostly about the success stories, but so far, Adasuve has been stuck in a kind of regulatory limbo. Many medications get stuck there because of safety or efficacy concerns, or simply because there isn’t sufficient money available to do the required testing.

Adasuve is also an example of how medications are sometimes effectively repatented by attaching new ways of administering the drugs to people. Loxaprine was approved by the FDA back in 1975, but this new inhalation procedure will allow the drug to be made non-generic again, at least when administered in a certain way. This can be good for ill people, since new ways of administering drugs are useful, but it can also drive up medication costs if patients aren’t aware of cheaper, generic alternatives.

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3. NuPathe Developing Risperidone Implant
4. AstraZeneca’s Suit to Stall Generic Versions of Quetiapine (Seroquel) Dismissed
5. Cariprazine Shows Promise, But Trial Worrisome