FDA

Earlier today, Sanofi-aventis (NYSE: SNY) announced that the FDA has approved Multaq 400 mg Tablets for patients with atrial fibrillation (AF) or atrial flutter (AFL).

Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.

Multaq is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

A U.S commercial launch planned for the summer of 2009.

Matrixx Initiatives (Nasdaq: MTXX) complaint data show "some degree" of loss of smell resulted in complaints by about 3.5 persons for every 100,000 units, according to according to Reuters from a FDA report.

Matrixx data shows peak rate for loss of smell was in 2004 with complaints reaching about 6.7 for every 100,000 units sold.

According to Reuters, the FDA inspector says Matrixx official said coordination of various procedures has improved over time.

Matrixx has bounced 29% to $7.08 on this story from Reuters.

Johnson & Johnson (NYSE: JNJ) and Elan Corporation plc (NYSE: ELN) announced a definitive agreement whereby Johnson & Johnson will acquire substantially all of the assets and rights of Elan related to its Alzheimer's Immunotherapy Program (AIP Program), through a newly formed company. In addition, Johnson & Johnson, through its affiliate, will invest $1 billion in Elan in exchange for newly issued American Depositary Receipts (ADRs) of Elan which will represent 18.4% of Elan's outstanding ordinary shares.

In consideration for the transfer of these rights and assets, Elan will receive a 49.9% equity interest in the newly formed Johnson & Johnson company that will acquire the AIP Program. Elan will be entitled to a 49.9% share of the profits and certain royalty payments upon the commercialization of products under the collaboration with Wyeth.

Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain.

The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox(R). Acura and King are currently evaluating the FDA's Complete Response Letter, and at this stage believe they can respond to the issues raised without conducting any additional studies. The Companies plan to meet with the FDA following submission of their response.

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of Aversion(R) (abuse deterrent) Technology product candidates and other innovative abuse deterrent technologies. Acura and King jointly developed Acurox(R) Tablets and are developing three additional opioid analgesic product candidates utilizing Aversion(R) Technology pursuant to a 2007 License, Development and Commercialization Agreement.[SM]

Shares of Sepracor, Inc. (Nasdaq: SEPR) have re-opened and are trading lower after an update on Clinical Trials for SEP-225289 and LUNESTA. Shares are down 16% to $15 per share.

Sepracor completed the analysis and validation of the preliminary results of a Phase II, 514-patient study evaluating the efficacy and safety of SEP-225289 for the treatment of Major Depressive Disorder, including patients with melancholic and atypical features. Sepracor determined that SEP-225289 did not meet the primary efficacy endpoint, which was a reduction in symptoms of depression following eight weeks of treatment, as assessed using the clinician-rated, 17-item HAM-D scale (Hamilton Depression Rating Scale, a standard scale used to assess depression in clinical trials and consisting of a list of symptoms commonly associated with depression). The positive control in the study (venlafaxine extended-release) did achieve separation from placebo that was statistically significant on the primary endpoint.

In this study, the measured serum concentrations of SEP-225289 were found to be below expected levels of exposure for both doses studied and were well below exposure profiles observed in several Phase I studies. Further, the adverse event profile demonstrated by SEP-225289 was inconsistent with prior clinical experience and was similar to the side effect profile observed when patients were administered placebo. As such, preliminary data are inconclusive pending further investigation of the dose exposure relationship of SEP-225289.

In 2008 and early 2009, Sepracor completed two pediatric studies of LUNESTA(R) brand eszopiclone in response to a Written Request from the United States Food and Drug Administration (FDA) in connection with its efforts to obtain a pediatric exclusivity extension for LUNESTA. In April 2009, Sepracor initiated two additional pediatric studies in accordance with the FDA's Written Request. The FDA has notified us that these two studies have been put on clinical hold due to its concerns regarding non-clinical data that could be relevant to the administration of eszopiclone in children. The clinical hold does not relate to any findings observed in the pediatric clinical studies nor does it impact any ongoing eszopiclone clinical trials in adults. In addition, this action does not impact the availability or prescribing information for LUNESTA in the treatment of adults with insomnia. LUNESTA has been proven to be safe and well tolerated in the treatment of adults and elderly patients with insomnia. Sepracor intends to work with the FDA to address the potential resolution of FDA's concerns regarding the non-clinical data with respect to human pediatric subjects.