Indiplon

Indiplon (INN and USAN) is a nonbenzodiazepine, hypnotic sedative being developed in 2 formulations - an immediate release product for sleep onset and a modified-release version for sleep maintenance.

Mode of action
Indiplon is said to work by enhancing the action of the inhibitory neurotransmitter GABA, like most other nonbenzodiazepine sedatives. Its primary function is to bind to BZ1 and Alpha1 subunits of the GABA-A receptors in the brain.

Availability
Indiplon was originally scheduled for release to doctors and pharmacies sometime in 2007, most likely in the springtime of that year, which is when Sanofi-Aventis' popular sleep aid, zolpidem, lost its patent rights in the United States and thus became available to patients as a much less expensive generic. Neurocrine Biosciences had planned to comarket indiplon in the US with Pfizer. However, following the issuing of a nonapprovable letter for the modified-release formulation and an approvable letter for the immediate-release version by the FDA (May 2006), Pfizer decided to end its relationship with Neurocrine.

The planned brand name has not yet been revealed to the public. Various setbacks have given cause for industry pundits to say that Indiplon will not become available until sometime in 2008 at the earliest. The delay has caused Neurocrine's stock value to drop significantly. The new drug application (NDA) was approved by the FDA in 1998, and since then, Neurocrine has been conducting clinical trials, with purportedly satisfactory results.

The impending availability of Indiplon is, as of mid-2007, unknown. Repeated problems getting the drug approved by the FDA has sent Neurocrine back to the drawing board numerous times since it first started development of the drug in the 1990s.

According to the FDA, capsules containing 5 mg and 10 mg are approvable pending additional submission of information to the FDA, but tablets containing 15 mg received a letter of disapproval indicating significant data are needed to refile with the FDA for further consideration.

It should also be noted that the domains indiplon.com and indiplon.net are both owned by domain squatters. Normally, when a company is developing a new product, they'll register, if possible, several domain names to promote the product. Neurocrine/Pfizer has curiously not done this, contrary to Pfizer's regular practice of doing so.