Noven Announces Results of Phase 3 Clinical Study of Once-Daily Lithium Product
Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that a Phase 3 clinical study of its developmental once-daily lithium carbonate product (“Lithium QD”) did not meet its primary endpoint with statistical significance (p-value ≤ 0.15).
The Phase 3 trial was a multi-center, double-blind, randomized, placebo-controlled, parallel-group study of Lithium QD. Approximately 240 subjects were randomized. The primary objectives of the four-week study were to determine the efficacy and safety of Lithium QD compared to placebo in the treatment of acute symptoms of mania in subjects with Bipolar I disorder. The primary efficacy endpoint was change from baseline compared to placebo using the Young Mania Rating Scale (YMRS).
“Both the Noven and JDS teams are very surprised and disappointed that the study did not achieve its primary endpoint,” said Robert C. Strauss, Noven’s President, CEO & Chairman. “We are currently analyzing the data to determine why statistical efficacy was not achieved.”
“Based on our understanding of the efficacy of lithium and the delivery profile of this formulation, we continue to believe that Lithium QD has the potential to be a valuable once-daily option in the lithium therapy category,” said Strauss. “Accordingly, we remain committed to the continued development of this important product. We plan to complete our analysis of the data and consult with the FDA regarding appropriate next steps to advance development.”
Lithium QD is subject to U.S. patents that extend to 2022 and may also benefit from three years of exclusivity under the Hatch-Waxman Act. Currently there are no FDA-approved once-daily lithium products on the market. The current U.S. market for lithium products, calculated at branded prices, is estimated to exceed $400 million annually.
Conference Call
A conference call relating to today’s news will be broadcast live via the Internet at www.noven.com beginning at 11:00 a.m. Eastern time this morning, October 8. Thereafter, a rebroadcast of the call will be accessible at the same website for at least two weeks. A replay of the conference call will be available from the afternoon of October 8 through October 10 by calling 877-660-6853 (from within the U.S.) or 201-612-7415 (from outside the U.S.) and entering the access code number 286 and ID number 258112.
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, has established itself as a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Its commercialized transdermal products include Vivelle-Dot® (estradiol transdermal system), the most prescribed estrogen patch in the U.S., and Daytrana™ (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD.
With the acquisition of JDS Pharmaceuticals in August 2007, Noven has become a broader-based specialty pharmaceutical company with the infrastructure, products and category expertise to market and sell products itself, and with a substantially enhanced late-stage product pipeline.
Products currently marketed through the JDS psychiatry sales infrastructure include Pexeva® (paroxetine mesylate) and Lithobid® (lithium carbonate). Pipeline products in psychiatry consist of Stavzor™ (delayed release valproic acid softgel), Lithium QD (once-daily lithium carbonate), and Stavzor™ ER (extended release valproic acid softgel). Pipeline products in women’s health consist of Mesafem™ (low-dose paroxetine mesylate), a non-hormonal product entering Phase 3 clinical trials for vasomotor symptoms (hot flashes).
See www.noven.com for additional information.
surf's up......crikey
AI
