NovaDel Pharma Inc announced that it has commenced a pilot pharmacokinetic feasibility study in humans using its lingual spray technology, to achieve a faster acting version of sumatriptan. Sales of sumatriptan, a migraine remedy marketed as Imitrex in the US by GlaxoSmithKline, are currently $1 billion plus.
The drug's new formulation utilizes NovaDel's patented lingual spray drug delivery technology to achieve more rapid onset of therapeutic activity. This is considered a desired benefit for patients suffering from a variety of medically treatable conditions, of which migraine headaches are a prime example.
"The study we have just commenced involves the administration of the test drug in a range of doses to human subjects to document the profile of blood levels achieved using our proprietary formulation of sumatriptan (Imitrex), an already approved and very successful product in its current pill form" said Gary A. Shangold, MD, NovaDel's chief executive officer.
If the study is successful in achieving the expected results, NovaDel would file an Investigational New Drug application to commence an abbreviated clinical development program designed to support a 505(b)(2) submission, a form of New Drug Application (NDA) that relies on data in previously approved NDAs and published literature. The 505(b)(2) would be filed under the agency's PDUFA guidelines and generally involves a 10-month review.