NovaDel Pharma Inc has filed U.S. patents enabling it to proceed with reformulation into lingual sprays of two clinically important drugs with current combined annual sales of over $2.4 Billion.
The company said the filings announced today cover lingually-delivered versions of the leading migraine remedy sumatriptan, marketed in the U.S. by Glaxo SmithKline under the brand name Imitrex, and zolpidem, the largest selling sleep-inducing agent, marketed in the U.S. by Sanofi as Ambien.
Both products are expected to benefit from the rapid onset of action provided by NovaDel's patented lingual delivery technology vs. the currently marketed pill formulations.
The technology utilizes the oral mucosa of the mouth to delivery drugs directly into the bloodstream, avoiding first pass liver metabolism. In the case of Ambien, NovaDel is predicting its lingual spray formulation will reduce onset of sleep to as little as 10 minutes, roughly half the time of the current pill, and it may also provide more clear-headed recovery.
With regard to Imitrex, NovaDel believes its lingual technology will at least match the 15-30 minutes to effective medication reportedly achieved by nasal formulations, but without irritation to the nasal passages. In pill form, Imitrex requires 1-1.5 hours to achieve maximum serum concentration.
Novadel said it expects to begin pilot pharmacokinetic studies on at least one of the compounds within the next 90 days. The PK studies will confirm the ability of NovaDel's patented lingual spray technology to provide rapid therapeutic blood levels of the test compound, while avoiding the GI route of administration and first-pass liver effects. These features are inherent in NovaDel's patented method of drug delivery which allows drugs to enter the blood stream directly through the oral mucosa lining the mouth.
Imitrex belongs to the triptan class of drugs which account for roughly $2.5 billion annual sales. They act on the brain's seratonin receptors to relieve the pain or discomfort of migraine and cluster headaches. NovaDel believes its proposed lingual formulation of sumatriptan will appeal not only to patients currently on Imitrex, but also users of other triptans who may find the lingual spray a preferred way to dose.
Drug-specific patent filings are the first step NovaDel routinely takes in readying itself for development of new products using its lingual delivery technology. The next steps are pilot and formal pharmacokinetic studies to determine the technology's utility with the target drug. Dose-ranging clinical trials would come next, followed by registration with the U.S. FDA under provisions of a 505(b)(2), an NDA which relies in part on data which has been previously generated by the drug's originator and in subsequent publications. The company indicated that review time for a 505(b)(2) is typically 10 months under PDUFA guidelines.