• Anesiva Inc., of South San Francisco, initiated a new Phase II study of Adlea (formerly 4975) for the relief of postoperative pain in patients undergoing total knee replacement surgery. Adlea is a long-acting, nonopiate analgesic designed to provide pain relief for weeks to months after a single local administration during the surgical procedure. The double-blind trial in about 80 patients will evaluate a higher dose of Adlea than in an earlier study. Anesiva said its goal is to initiate other clinical trials of Adlea in the coming months: a Phase II study in management of acute postoperative pain associated with orthopedic surgeries, a Phase II/III trial for management of osteoarthritis pain in the knee and a Phase III trial in knee replacement surgery.

• Critical Therapeutics Inc., of Lexington, Mass., reported publication of trial results showing Zyflo (zileuton) extended-release tablets demonstrated significantly improved lung function in moderate persistent asthma patients compared to placebo. Data from that Phase III trial were published in the Annals of Allergy, Asthma & Immunology. Separately, results from a trial of the immediate-release formulation of zileuton, Zyflo tablets, demonstrating safety in patients with chronic asthma were published in the Drug Safety edition of the Official Journal of the International Society of Pharmacovigilance.

• Medivir AB, of Stockholm, Sweden, said its Phase III program for Lipsovir (ME-609) has enrolled and issued study drug to all the intended patients. In two of the three studies, the final patient has commenced treatment. The product is being developed to treat labial herpes, or cold sores. One Phase III study, in 240 children and adolescents in Sweden and Russia, is designed to confirm safety in that group. The second study is being performed on immunocompromised patients with cold sores. It includes 200 patients in Russia and the Ukraine. The third study is the pivotal trial, and has enrolled patients with recurrent cold sores. It is being performed in 2,400 patients in North America, and includes acyclovir and placebo arms. Medivir expects to have results from the whole program in the first quarter of 2008. It then intends to enter one or more partnerships on the product.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., and Takeda Pharmaceuticals North America Inc., of Deerfield, Ill., said the first patient has been enrolled in a Phase III study of lubiprostone (24 mcg, oral gel capsules, twice daily) for treating opioid-induced bowel dysfunction. The pivotal program consists of two 12-week, double-blind studies, followed by a nine-month open-label safety extension study. The double-blind studies are expected to enroll about 840 patients in the U.S. and Canada. Lubiprostone is a chloride channel activator already approved as Amitiza for treating chronic idiopathic constipation in adults. It also is under FDA review for irritable bowel syndrome with constipation.

• Targanta Therapeutics Corp., of Cambridge, Mass., initiated a Phase II trial investigating the safety and efficacy of oritavancin in complicated skin and skin structure infections. The study will evaluate single or infrequent doses of oritavancin, a semi-synthetic lipoglycopeptide antibiotic agent. The international, randomized, double-blind, controlled study will enroll patients with cSSSIs presumed or proved to be caused by a Gram-positive pathogen. The primary endpoint of the 300-patient study is clinical responses (either cure or improvement vs. failure).