FDA Calendar Updates: Transdel, Javelin, Jazz, Par Pharma

by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA.

With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Transdel Pharma (OTC:TDLP): On 6/15/09, TDLP.OB announced that the Company anticipates reporting top-line results from their current Phase 3 study of Ketotransdel during 3Q09. The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug (NSAID), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the U.S. and will enroll about 350 patients. TDLP plans to initially seek FDA approval of Ketotransdel for the treatment of acute pain and then expand the label to include additional indications such as osteoarthritis. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
Javelin Pharma (AMEX:JAV): On 6/15/09, JAV reported results from a new Phase 1 pharmacokinetic and safety study of Dyloject in patients with mild to moderate renal (kidney) and mild hepatic (liver) impairment. Dyloject was well tolerated in these higher risk patient populations. The elimination rate of Dyloject's active ingredient diclofenac was statistically indistinguishable in all three patient groups compared with matched healthy controls. The Company plans to file a NDA for Dyloject with the FDA for U.S. marketing approval during the fall of 2009 at the same dose used in these studies. Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness across all five primary study endpoints.
Jazz Pharma (NASDAQ:JAZZ): On 6/15/09, JAZZ announced that sodium oxybate (JZP-6) demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase 3 data presented last week. JAZZ has also completed its second Phase 3 clinical trial of JZP-6 and expects to announce top-line results from this study around mid-2009. Assuming positive results for the second study, the company anticipates submitting a NDA for sodium oxybate for the treatment of fibromyalgia to the FDA by the end of 2009. UCB SA [EBR:UCB] (OTCPK:UCBJF) anticipates filing in the EU shortly after. UCBJF.PK has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North America and will manage registrations accordingly.
On 6/15/09, BioAlliance Pharma [EPA:BIO] announced the submission of its New Drug Application (NDA) to the FDA for the approval of Loramyc (miconazole) Mucoadhesive Buccal Tablets, developed for the treatment of OroPharyngeal Candidiasis (better known as thrush). If approved, Strativa Pharma, the specialty pharma division of Par Pharma (NYSE: PRX) (which is BioAlliance Pharma’s partner for commercialization in the U.S.) could launch Loramyc in the second half of 2010.
Disclosure: No positions.