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DOV Pharmaceutical Reports Results Of End Of Phase 2 Meeting With FDA And Agreement On Clinical Development Program



10/19/2005 5:10:39 PM

HACKENSACK, N.J., April 1 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced today that on March 30, 2004, it participated in an End of Phase 2 Meeting with representatives of the FDA's Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products. DOV requested the meeting to review its Phase 3 development plan and NDA registration strategy for bicifadine. DOV intends to seek approval of bicifadine for the treatment of acute pain and chronic back pain. DOV and the FDA reached agreement on a plan for the balance of the Phase 3 program under the following guidelines:

-- For an acute pain indication, DOV is expected to provide evidence demonstrating bicifadine's analgesic properties in three pivotal, multiple dose pain models, one of which will require replication. -- For a chronic back pain indication, DOV is expected to provide positive results from two placebo controlled dose-response studies of three months' treatment duration. -- DOV will need to obtain long-term safety observations from at least 100 patients treated with bicifadine for one year and 300 patients treated with bicifadine for 6 months. DOV had proposed such clinical safety data in support of a chronic back pain indication. The FDA indicated that these data are now required to support an acute pain indication because the agency anticipates that an analgesic approved for short-term use may have substantial off-label use in other types of pain, including chronic pain.

The FDA did not express any particular concerns regarding the safety profile of bicifadine based on the results of preclinical and clinical testing, including observations from previously conducted clinical trials in which over 1500 subjects received bicifadine.

During the second quarter of 2004, DOV will, together with the FDA, finalize the designs and assessments to be included in two pivotal protocols during special protocol review meetings. In the third quarter of 2004, DOV anticipates initiation of two pivotal Phase 3 studies, the first a five-day acute, post-surgical bunionectomy trial and the second a three-month chronic back pain study.

This meeting was of special importance to DOV because the FDA does not currently provide published guidance to assist sponsors in the planning of their analgesia programs. Prior to the meeting, DOV had provided the FDA with detailed summaries of the results of two placebo controlled, dose-response studies of bicifadine in patients with pain following dental surgery. The data showed statistically and clinically significant effects of bicifadine relative to placebo with maximal efficacy at least comparable to that of the active controls, codeine and tramadol. In addition, DOV provided the FDA with detailed summary results of other clinical trials and the full animal pharmacology and toxicology testing program.

Dr. Arnold Lippa, CEO of DOV commented, "We are pleased to have this guidance from the FDA at a time when published guidance for analgesia does not exist and we now have confirmation of the regulatory path ahead of us. The agency's clinical and regulatory requirements are consistent with DOV's pre-meeting timetable for filing an NDA in 2006."

Ocinaplon

On March 30, 2004, DOV received an informal communication from the FDA's Division of Neuropharmacology regarding the clinical status of ocinaplon, DOV's product candidate for the treatment of generalized anxiety disorder, currently on clinical hold. The agency has informed DOV that it will require additional time to allow an independent hepatologist to review data submitted by DOV.

DOV is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular, that involve alterations in neuronal processing. The company has six product candidates in clinical trials addressing therapeutic indications with significant unmet needs.

Cautionary Note:

Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:

-- demonstrate the safety and efficacy of product candidates at each stage of development; -- meet our development schedule for our product candidates; -- meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all; -- meet obligations and achieve milestones under our license and other agreements; -- meet obtain collaborations as required with pharmaceutical partners; -- obtain substantial additional funds; -- obtain and maintain all necessary patents or licenses; and -- produce drug candidates in commercial quantities at reasonable costs and compete successfully against other products and companies.

Other factors that may cause our actual results to differ materially from our forward-looking statements include the fact that we or the FDA may suspend one or more of our clinical trials, patient recruitment may be slower than expected or patients may drop out of our clinical trials and our success depends on the performance of our licensees and collaborative partners who among other things may not fulfill their obligations to us. You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K filed on March 15, 2004. We qualify all our forward-looking statements by these cautionary statements. There may be other factors that may materially affect our forward-looking statements and our future results. Readers should not, therefore, place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.

DOV Pharmaceutical, Inc.

CONTACT: Barbara Duncan, Chief Financial Officer of DOV Pharmaceutical,Inc., +1-201-968-0980; or Kathleen Eppolito of Scientia Communications, Inc.,+1-718-281-1809, for DOV Pharmaceutical, Inc.


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