On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects.
Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo NDA resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million.
On 11/23/09, ProUroCare (OTC: PUMD.OB) announced that a 510(k) submission for U.S. market clearance of a prostate mechanical imaging system has been filed with the FDA, seeking a labeling claim for the device as an aid to visualize and document abnormalities of the prostate detected and/or monitored by digital rectal examination (DRE). The system incorporates the company’s unique and patented tactile elasticity imaging technology that creates a “map” of the prostate and an electronic record that can be stored for future analysis.
On 10/8/09, announced the completion of a National Institute of Health and National Cancer Institute-supported clinical study. The study's purpose was to evaluate the ability of the company's ProUroScan imaging system to visualize and document abnormalities in the prostate detected or monitored by the DRE. The ProUroScan imaging system is designed to complement the DRE, and to provide patients with potential prostate abnormalities the ability to have their prostates imaged in real time with records electronically stored for later comparison.
On 11/23/09, SciClone Pharma (NASDAQ: SCLN) announced that patient enrollment is complete ahead of schedule for its Phase 2 trial of SCV-07, which is a small molecule synthetic peptide with immune-modulating properties, for the treatment of severe oral mucositis (OM) in patients with head and neck cancer. Top-line results of the oral mucositis trial are expected to be announced during 1H10.
The multi-center, randomized, double-blind, placebo-controlled, dose ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of OM in patients receiving standard chemo-radiation therapy for treatment of cancers of the head and neck. SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells.
On 11/23/09, ARCA biopharma (NASDAQ: ABIO) announced that the FDA has designated as a Fast Track development program the investigation of Gencaro, the Company’s experimental, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. Last week, ABIO stated that it intends to submit a study protocol during 4Q09 for review under the FDA’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.
ARCA anticipates that the proposed trial protocol will be a superiority comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. Subject to the timing and outcome of the Agency’s review of the SPA submission, and subject to the Company’s ability to obtain sufficient funding, the Company currently expects it could begin the proposed trial in late 2010 or 1H11. On 6/1/09, ABIO announced that it received a CRL from the FDA for the Gencaro NDA for the treatment of patients with chronic heart failure.
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