Posts tagged ‘NDA’

Transcept INTERMEZZO PDUFA Date

Transcept Pharmaceuticals (TSPT) is getting ready for it’s third Annual PDUFA Date coming up for INTERMEZZO for insomnia on Nov 27, 2011.  I think the results will be the same.  Why?  Because if you keep doing the same thing (submit NDAs with the same data) you can expect to get the same result – NFC from the FDA – Not Favorably Considered.

The FDA told them they had a problem with the dose in women, ie, it might be too high and there might be some carry over effects upon awakening that could present a problem.  In other words, the benefit risk ratio was tilted in the direction of risk.  So, the company lowers the dose in women by half, reducing the risk.  But what about the benefit side of the equation if you reduce the dose by half?  I don’t think they have the adequate and well controlled study on that.  So, we’ll probably get a chance to comment on this again next year when they celebrate their Fourth Annual PDUFA Date for this drug.

LORQESS – one more time!

Arena Pharmaceuticals has submitted information on their one year study of LORQESS (lorcaserin) to the FDA to support their NDA application for the drug in treating obesity.  We, as well as others have provided opinions on the likelihood of Arena being successful, the Advisory Committee did not recommend approval and the FDA has not approved LORQESS.  Yet, Arena keeps trying.

The new one year data provide some additional information on the efficacy that still isn’t enough to convince me that the drug is at least meeting the minimum requirements of the FDA Guidelines for Obesity Drugs.  I can’t even say that the results are marginal.  At the end of a year, LORQESS patients showed a 4.5% weight loss from baseline compared to a 1.5% weight loss for placebo patients.
By far, the most alarming data in the one year study are the reports of study patients who showed heart valve problems.  The LORQESS patient group reported 2.9% of patients with heart valve problems vs. only 0.5% reported for the placebo group. 

Doesn’t anyone at Arena remember all the heart valve problems with diet drugs 10 years ago?  C’mon, somebody take the shovel away from them – the hole is deep enough already!

PDUFA Date – STACCATO loxapine

October 11, 2010 is the PDUFA Date for Alexza Pharmaceuticals STACCATO loxapine, an inhalation formulation of loxapine intended for rapid treatment of schizophrenia and bipolar disorders.  The company reports that this is the first NDA that it has submitted using the STACCATO inhalation technology.  Phase III clinical studies are reported as having been submitted that support both indications but few details are available other than reports that both primary and secondary endpoints were met.  Getting approval for both indications using new technology seems like a bit of a hurdle for a company that is submitting its first NDA.