Valeant Onsolis soluble film approved in Canada, EnVivo initiates Phase IIb Alzheimer's trial for EVP-6124;

> The Canadian regulatory authority has approved the use of Valeant Canada's Onsolis (fentanyl buccal soluble film), an opioid analgesic indicated for the management of breakthrough pain in cancer patients. Onsolis will be the first available fentanyl product with rapid onset of action approved in Canada and is expected to be available for patients in the third quarter of 2010. Onsolis uses a patented delivery system designed to provide rapid and reliable delivery of fentanyl for the treatment of breakthrough pain in adult cancer patients. Valeant release

> EnVivo Pharmaceuticals has begun dosing of patients in a Phase IIb study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with mild to moderate Alzheimer's disease. EVP-6124 is a selective agonist for the alpha-7 subtype of the nicotinic acetylcholine receptor and is being developed by EnVivo for potential cognitive enhancement in both schizophrenia and Alzheimer's patients. It has been shown to have excellent CNS penetration, oral bioavailability, pharmacokinetics and metabolic profile. EnVivo release

> Cypress Biosciences has advised AlphaRx that it will not be funding development of Indaflex, a semi-solid osteoarthritis cream formulation treatment for topical administration, containing the active ingredient Indomethacin. Indaflex Cream is composed of a highly-dispersed colloidal suspension of nano-sized oil droplets, loaded with active drug and suspended in an aqueous phase. Notwithstanding the termination of all Indaflex activity in the US, AlphaRx says it will continue to develop Indaflex for the Chinese market. Alpharx release (.pdf)

> Poniard Pharmaceuticals will present results of its Phase III  trial at the American Society of Clinical Oncology 2010 Annual Meeting, June 4-8 in Chicago, IL. (Click here for more info). The study evaluated the efficacy and safety of picoplatin as a second-line treatment in small cell lung cancer (SCLC). Picoplatin is a new and differentiated platinum-based chemotherapeutic agent that is in clinical development for multiple cancer indications, treatment combinations and by two routes of administration. It is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Poniard release

> Despite years of warnings from the FDA on the risk of worsening asthma symptoms and death associated with the practice, nearly one-third of asthma patients are taking long-acting beta agonists (LABAs) alone, and not in combination with other asthma control medications. This according to a new study from the Medco Research Institute and the Medco Pulmonary Therapeutic Resource Center, presented at the 2010 Eastern Allergy Conference. The National Heart, Lung and Blood Institute asthma treatment guidelines recommend that LABAs should be used in combination with inhaled corticosteroids or leukotriene modifiers for the treatment of asthma, and not used as monotherapy, due to the potential risks of asthma-related hospitalizations, intubations and death. Medco release

> Tests from International Stem Cell confirm that its lab-grown corneal tissue closely mimics the drug absorption and drug metabolism characteristics found in normal corneal tissue. Two sets of collaborative experiments between ISCO and Absorption Systems have shown that corneal tissue cultured by ISCO exhibits topical drug absorption barrier properties and tissue-appropriate enzymatic activity, making it a promising model for studying human ocular drug absorption as an alternative to live animal testing. Release (.pdf)

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