Amag Pharmaceuticals Inc., of Waltham, Mass., said data from a multi-institutional trial of Mugard has been published in Cancer. The phase IV randomized, double-blind, placebo-controlled trial showed Mugard was more effective than a sham-control in significantly reducing the mouth and throat soreness associated with oral mucositis, a common side effect of radiotherapy used to treat patients with head and neck cancer. Of 120 patients participating in the trial, 60 received Mugard and 60 received saline-bicarbonate rinse as a sham-control. The study's primary endpoint was a reduction in mouth and throat soreness as assessed daily by a validated patient questionnaire. Compared to control patients, Mugard-treated patients had significantly less mouth and throat soreness over the course of the study. Mugard was FDA-approved for oral mucositis in cancer patients in 2006.

Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said a post-hoc analysis of the phase III STAR trial comparing Nuedexta (dextromethorphan HBr and quinidine sulfate) to placebo in treating pseudobulbar affect (PBA) showed that 19 percent of treated patients achieved remission from PBA symptoms after one week of treatment. Approximately 50 percent of treated patients achieved remission by the end of the 12-week trial, and sustained episode remission rates in patients treated with Nuedexta were higher than placebo throughout the trial. Remission was defined as no episodes for the remainder of the study and a minimum of 14 days prior to completion or drop-out. The company also reported findings from a multicenter, double-blind, placebo-controlled study in which migraine sufferers were randomized to self-administer AVP-825, a breath-powered powder sumatriptan intranasal treatment, or placebo to treat moderate to severe migraine pain. Migraine relief for some patients began as early as 15 minutes following treatment, and a statistically significant greater number of treated patients experienced headache relief compared to placebo at all time points from 30 minutes through two hours. At two hours after taking the medication, seven of 10 treated patients reported they had meaningful pain relief. No serious adverse events were associated with the treatment. Details from these and other studies are scheduled to be reported at the American Academy of Neurology annual meeting in Philadelphia.

Brainstorm Cell Therapeutics Inc., of New York and Petach Tikvah, Israel, said the FDA approved commencement of its phase II trial with Nurown in patients with amyotrophic lateral sclerosis (ALS). The randomized, double-blind, placebo-controlled multicenter study is designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF or Nurwwn) in 48 ALS patients. The cells will be administered via combined intramuscular and intrathecal injection. Patients will be followed monthly for approximately three months before transplantation and six months following transplantation. The primary objective of the study will be safety and tolerability, as defined by a measure of the number of patients with adverse events. Secondary endpoints will measure a change in the ALS Functional Rating Scale and a change in Slow Vital Capacity slopes.

Civitas Therapeutics Inc., of Chelsea, Mass. reported positive results from a phase IIb trial of CVT-301, an inhaled formulation of levodopa that it's developing for the treatment of Parkinson's disease. The study met its primary endpoint, achieving a clinically important and statistically significant reduction in average Unified Parkinson's Disease Rating Scale Part 3 motor score vs. placebo. The company is reporting the results at the 66th Annual American Academy of Neurology Meeting Tuesday in Philadelphia.

Genervon Biopharmaceuticals LLC, of Pasadena, Calif., reported that it successfully completed a phase IIa trial for amyotrophic lateral sclerosis (ALS) disease modification and expects to complete a full analysis of the trial's results in the third quarter of 2014. The company said preliminary data suggested that the experimental therapy, GM604, shows "significant promise." At 10 weeks following completion of dosing and without further treatment, clinical measurements of ALS progression remained the same and unchanged from the baseline in two of the trial's eight patients, while the rates of degradation of those clinical measurements had slowed in five of the remaining six treated patients, the company said.

Hospira Inc. reported results from a post-authorization observational safety study of its biosimilar epoetin product Retacrit/Silapo (epoetin zeta) in patients with renal anemia conducted in Europe. The Lake Forest, Ill.-based company said that Retacrit/Silapo appeared to be as safe as other epoetin alfa products. Retacrit is marketed in Europe by Hospira, and Silapo is marketed in Germany by Cell Pharm GmbH, a subsidiary of Stada Arzneimittel AG.

Intelgenx Corp., of St. Laurent, Quebec, and Redhill Biopharma Ltd., of Tel-Aviv, Israel, initiated a comparative bioavailability clinical study comparing their anti-migraine Versafilm to the European reference drug. It is intended to support the planned submission of a European Marketing Authorization Application for the oral thin film formulation of rizatriptan for the treatment of acute migraines. Results of the bioavailability study are anticipated by June 2014.

Ironshore Pharmaceuticals & Development Inc., a subsidiary of Toronto's Highland Therapeutics Inc., has begun enrollment in a phase III study of HLD-200, the company's formulation of the stimulant methylphenidate, in children with attention-deficit hyperactivity disorder. The company expects to complete the study in the fourth quarter of 2014.

Xoma Corp., of Berkeley, Calif., said that, based on its meeting with the FDA, plans are being finalized for a gevokizumab phase III program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. The phase III program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The primary endpoint is complete wound closure of the target ulcer at approximately four months.