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DOV Pharmaceutical, Inc. Initiates Phase III Trial of Bicifadine for Treatment of Post-Operative Pain Following Vaginal Hysterectomy

Posted on: Thursday, 4 August 2005, 18:01 CDT

HACKENSACK, N.J., Aug. 4 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced it has initiated a phase III U.S. clinical trial of bicifadine, its novel analgesic, in the treatment of post-operative pain following vaginal hysterectomy.

The clinical trial is a randomized, multicenter (20-30 sites), parallel, placebo controlled trial with 100 patients per treatment arm (bicifadine 400 mg tid or placebo). Study medication will be administered for up to five days in patients who experience moderate to severe pain following surgery. The primary efficacy endpoints are the patients' assessment of pain intensity using a categorical scale and pain relief based on changes in pain intensity using a visual analog scale of pain ratings. Secondary endpoints include, among others, time to onset of pain relief, use of analgesic rescue medication and the patient's global evaluation. These primary and secondary efficacy endpoints are widely recognized measures of analgesic efficacy. The clinical trial is one of four pivotal studies required by the FDA to support an NDA filing for an acute pain indication.

Dr. Warren Stern, DOV's Senior Vice President of Drug Development, said, "This clinical trial provides another informative model for evaluating the safety and efficacy of bicifadine in the management of acute pain. Other ongoing phase III clinical trials for bicifadine include double-blind placebo controlled evaluations of several bicifadine dosing regimens in patients with pain following bunionectomy surgery and in patients with chronic lower back pain. Also ongoing, is a phase III long-term open label clinical trial study in patients with chronic lower back pain, a trial that utilizes standard of care as a control treatment."

About Bicifadine

Bicifadine is a chemically novel molecule with a unique profile of pharmacological activity. In regard to mechanism of action it is a balanced SNRI (serotonin and norepinephrine reuptake inhibitor) and is not an opiate nor NSAID (nonsteroidal anti-inflammatory drug) nor a COX-2 inhibitor. In animal models, bicifadine does not demonstrate any significant abuse liability, addiction or dependence potential.

Bicifadine has also demonstrated statistically significant analgesic effects in two placebo controlled clinical trials in patients with pain following third molar dental surgery.

Drugs for the treatment of pain, or analgesics, have historically been placed into one of two general categories:

* narcotics, e.g., morphine, codeine, Demerol and Percodan; and * non-narcotic prostaglandin inhibitors, e.g., aspirin, acetaminophen, ibuprofen and COX-2 inhibitors.

While drugs in both of these categories are regularly used in the treatment of pain, their use has been limited because of various side effect profiles. In addition, administering these drugs for extended durations has been problematic. Although prostaglandin inhibitors have been used for the treatment of pain, particularly pain associated with inflammation, their efficacy is often limited to milder types of pain and they may display undesirable side effects relating to the gastrointestinal tract and the liver. Narcotics are also used to treat pain, but tolerance develops rapidly and higher doses eventually lead to physical dependence and additional side effects, including constipation and respiratory depression. Therefore, DOV believes patients with moderate to severe pain will benefit from the use of bicifadine.

DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular, that involve alterations in neuronal processing. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, pain, anxiety, and depression. Our partner Neurocrine Biosciences, Inc. has filed two NDAs for the use of DOV's product candidate indiplon for the treatment of insomnia.

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, including with respect to clinical trial initiation, enrollment and completion; * meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all; * meet obligations and required milestones under our license and other agreements; * obtain and maintain 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.

Factors that may cause our actual results to differ materially from our forward-looking statements include (i) one or more of our product candidates could be shown to cause harmful side effects, (ii) one or more of our product candidates may not exhibit the expected therapeutic results, (iii) we or the FDA may suspend one or more of our clinical trials, (iv) patient recruitment may be slower than expected or patients may drop out of our clinical trials, (v) regulatory approval for our product candidates may not be received or may be delayed, and (vi) performance of our licensees and collaborative partners on whom our success depends 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, 2005. 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, or Alan Beckhard,Manager, Investor Relations and Corporate Communications, both of DOVPharmaceutical, Inc., +1-201-968-0980

Web site: http://www.dovpharm.com/

Source: PRNewswire-FirstCall

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