T-62
Company: King Pharmaceuticals, Inc.
Initiated Phase 2 Clinical Trial Evaluating T-62 as a Treatment for Neuropathic Pain, December 26, 2008
Company Comments: The Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in up to 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design.
LATISSE (bimatoprost ophthalmic solution)
Company: Allergan, Inc.
FDA approved LATISSE (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes, December 26, 2008
Company Comments: LATISSE is the first science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness, and darkness of eyelashes.
Degarelix
Company: Ferring Pharmaceuticals, USA
Received FDA Approval of Degarelix for Treatment of Advanced Prostate Cancer, December 24, 2008
Company Comments: Degarelix is the only GnRH receptor antagonist approved by the FDA for the treatment of hormonally-sensitive advanced prostate cancer. Degarelix achieves medical castration differently than LHRH agonists, specifically by binding reversibly to GnRH receptors on cells in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone.
R3487/MEM 3454
Company: Memory Pharmaceuticals
Initiated Biomarker Study of R3487/MEM 3454 in Schizophrenia, December 24, 2008
Company Comments: The study will evaluate the effect of four doses of R3487/MEM 3454 on electrophysiological biomarkers (such as P50 sensory gating) that have been shown to be closely associated with schizophrenia.
Hydromorphone HCl 2 mg tablets
Company: ETHEX Corporation
Recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets, December 23, 2008
Company Comments: ETHEX Corporation announced that it voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 03/2010; NDC 58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets.
Acetazolamide
Company: X-GEN Pharmaceuticals
Received FDA Approval for AcetaZOLAMIDE for Injection USP, December 22, 2008
Company Comments: Acetazolamide for Injection USP is indicated for adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, un-localized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.
Vasovist (gadofosveset trisodium)
Company: EPIX Pharmaceuticals, Inc.
Received FDA Approval, December 22, 2008
Company Comments: EPIX Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved for marketing its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium), to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
NPSP558
Company: NPS Pharmaceuticals
Initiated Phase 3 ‘REPLACE’ Study of NPSP558 in Hypoparathyroidism patients, December 22, 2008
Company Comments: REPLACE is a double-blind, placebo-controlled trial that will randomize approximately 110 patients at over a dozen sites in the United States, Canada, and Europe. The primary objective is to demonstrate, over a 24-week treatment period, that once-daily subcutaneous dosing with NPSP558 at doses of 50g, 75g, or 100g is a safe and effective hormone replacement therapy for the treatment of patients with hypoparathyroidism.
Zolpimist (zolpidem tartrate)
Company: NovaDel Pharma Inc.
Received FDA Approval of Zolpimist 5 mg and 10 mg Oral Spray, December 22, 2008
Company Comments: NovaDel Pharma Inc. announced that Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
SCV-07
Company: SciClone Pharmaceuticals, Inc.
First Patient Enrolled in Phase 2 Clinical Trial Using SCV-07 to Prevent Oral Mucositis, December 22, 2008
Company Comments: The first patient was enrolled in the phase 2 trial at the University of Alabama at Birmingham. The study will be conducted at approximately 15 to 20 centers in the United States, and will include three treatment cohorts of 20 patients each.
Filed Under: Drug Discovery
