Resubmission of Intermezzo NDA
Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are:
- Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo dose for men at 3.5 mg.
- There will be new labeling instructions that state Intermezzo should only be taken if patients have at least 4 hours of bedtime remaining, and that patients should refrain from driving for at least 1 hour after arising and until 5 hours after dosing Intermezzo.
- The company does not plan to conduct additional studies prior to the resubmission of the Intermezzo NDA.
Transcept expects to resubmit the NDA by the end of September 2011. The company said that FDA stated that if the planned resubmission is adequately concise in summarizing morning zolpidem levels and provides evidence that the levels are safe given the proposed labeling, it may be able to consider the resubmission as a two-month, Class 1 review under FDA guidelines. The company should receive notification two weeks after submission as to whether the review is Class I or Class II, which is a six month review.
I was shocked by the Complete Response Letter that Transcept received on July 14, which seemed to clearly indicate that a new phase III driving trial on Intermezzo would have to be conducted in order to gain approval. This would have entailed a delay of two to three years to conduct the trial. I have consistently felt that Intermezzo fills a much needed role in the insomnia market and should be approved, but the FDA seemed to be going out of its way to put roadblocks in front of approval.
The new scenario laid out by Transcept is the best imaginable scenario. However, my head is spinning. The initial Complete Response Letter and the resubmission requirements as described by Transcept are at opposite ends of the spectrum. The decision process at FDA on this drug is utterly baffling.
I think that the drug should be approved and hope that it will, but for the time being I am remaining neutral and on the sidelines. I think that the first key event to watch will be if the FDA designates this as a Class I response. As noted previously, this should occur in mid-October.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.