DOV: FDA says studies sufficient to submit NDA for bicifadine

By E. Janene Geiss

Philadelphia, Feb. 13 - DOV Pharmaceutical, Inc. said Sunday that its chronic low-back pain program, including its long-term safety database, is sufficient for the company to submit the planned New Drug Application for bicifadine, its novel analgesic.

This outcome came about as a result of a strategy meeting initiated by DOV with the Food and Drug Administration to discuss the company's chronic pain program, according to a company news release.

In the meeting, DOV said it also confirmed that the use of a single primary endpoint in its two pivotal phase 3 clinical trials of bicifadine in chronic low-back pain - reduction in pain from baseline to end of treatment as measured by the Visual Analog Scale - is acceptable to the FDA.

DOV also said it will perform a Qtc study in humans as it appears this is an emerging standard for all New Molecular Entities. A Qtc study measures intervals in the QT portion of an electrocardiogram and assesses a drug's potential to produce changes in cardiac rhythm.

To date, there have been no electrocardiogram - or other - safety concerns in DOV's preclinical studies or in clinical studies involving more than 2,500 subjects treated with bicifadine, officials said.

As a result of the meeting, DOV said it reiterates its expectation to submit its NDA for bicifadine in the first half of 2007.

"This was a key first meeting with the newly merged FDA division responsible for analgesia drugs," Leslie Hudson, chief executive officer, said in the release.

"The meeting and its outcomes represent an important milestone in our development of bicifadine. To date, we have seen very encouraging data from our open label phase 3 trial and we continue to believe that bicifadine could meet a very significant medical need for a safe and effective analgesic."

The ongoing results from DOV's long-term open-label trial of bicifadine in chronic low-back pain suggest that bicifadine is at least as effective as standard of care in treating chronic low-back pain and is safe and well-tolerated.

The data trends reported by DOV at its annual scientific symposium in October and in a year-end update provided by the company in December are continuing with dosing now spanning 12 months and total patients enrolled in study 022 exceeding 700, officials said.

As part of its ongoing bicifadine development plan, DOV also announced that it has closed the highest dose arm - 400 mg - in its second pivotal phase 3 clinical trial of bicifadine in chronic low-back pain because open-label data from the company's long-term safety and efficacy trial of bicifadine in chronic low-back pain indicate no incremental benefit at this higher dose, officials said.

Closing this study arm will allow DOV to focus its development efforts on the dosing regimens it believes show the highest likelihood of success in chronic low-back pain - 200 mg, 300 mg and 400 mg, officials said.

The closing of the 400 mg arm will shorten the time to completion of the clinical trial and DOV said it now expects to report the results of the study earlier in the fourth quarter of 2006 than previously planned.

Bicifadine is being evaluated in four phase 3 clinical trials: three in chronic low-back pain patients and one in patients suffering pain after vaginal hysterectomy and two phase 2 clinical trials: one in patients with osteoarthritis of the hip or knee and one in patients with painful diabetic peripheral neuropathy.

Phase 3 clinical trials have already demonstrated that bicifadine is effective in treating severe to moderate pain following dental surgery and bunionectomy, officials said.

DOV is a Hackensack, N.J., biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system and cardiovascular disorders.

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