The Food and Drug Administration's (FDA) Anesthetic and Life-Support Drugs Advisory Committee voted in August to expand indications for the antidepressant medication Cymbalta (duloxetine) to include treatment of chronic pain. By a vote of 8 to 5, with one abstention, the committee voted "yes" in answer to the following question: "Does the data from the clinical trials provide adequate evidence of efficacy for the management of chronic low back pain?" But by a vote of 9 to 4, with one abstention, the committee voted "no" in answer to the question: "Does the data from the clinical trials provide adequate evidence of efficacy for the treatment of chronic pain due to osteoarthritis?"
The FDA approved supplemental new drug applications for Saprhis (asenapine) sublingual tablets to expand the product's indications for the treatment of schizophrenia in adults as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It also approved the tablets as adjunctive therapy with either lithium or valproate for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Saphris was initially approved in the United States in August 2009 for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
Silenor (doxepin) is now available in the United States for treatment of insomnia characterized by difficulty with sleep maintenance. The FDA approved the drug for that indication in March. The drug is manufactured by Somaxon Pharmaceuticals in San Diego. The company signed an agreement in August with Procter and Gamble's health care division to co-promote Silenor in the United States.
Shire announced in August the divestiture of Daytrana (methylphenidate transdermal system) to Noven Pharmaceuticals. Daytrana, which is approved and marketed in the United States for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, will continue to be available for patients through Noven. The FDA approved Daytrana as a treatment for ADHD in children in April 2006 and adolescents this past June.
Roche and reMYND announced an agreement to develop novel therapeutics to slow neurodegeneration in Parkinson's and Alzheimer's patients by inhibiting alpha-synuclein and tau toxicity. The collaboration will focus on two of reMYND's preclinical, small-molecule programs targeting alpha-synuclein and tau-related pathologies. Roche will be responsible for preclinical and clinical development and for worldwide commercialization, while reMYND will continue to conduct nonclinical pharmacology studies to elucidate underlying molecular mechanisms. ReMYND's compounds are believed to inhibit alpha-synuclein neurotoxicity in Parkinson's disease and tau neurotoxicity in Alzheimer's disease. As such they are considered to be disease modifying, as opposed to merely symptom treatments.
Eli Lilly and Co. announced in August that it plans to halt the development of semagacestat, a potential treatment for Alzheimer's disease. Two phase 3 trials showed that the treatment did not slow the progression of the disease and had an adverse effect on cognition and ability to perform daily activities. The studies also showed that semagacestat was associated with an increased risk of skin cancer.
Rexahn Pharmaceuticals Inc. announced in September that it has submitted a phase 2b protocol to the FDA for the clinical study of Serdaxin for treatment of major depressive disorder. The phase 2b study will assess Serdaxin's efficacy as a treatment for major depressive disorder in approximately 300 subjects. The planned double-blind, randomized, placebo-controlled trial will be conducted at multiple sites in the United States and will measure the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary efficacy endpoint.