Acura Pharmaceuticals Inc., of Palatine, Ill., said it filed an investigational new drug application with the FDA for clinical testing of its hydrocodone bitartrate with acetaminophen formulated using its Aversion Technology. Acura intends to complete clinical testing for a new drug submission via the 505(b)(2) pathway in the first half of 2014. BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the

Merck and Co Inc., of Whitehouse Station, N.J., reported that its large study of Tredaptive (extended-release niacin/laropiprant) missed its primary endpoint. The trial enrolled 25,673 patients at high risk for cardiovascular events, and followed them for a median of 3.9 years while they received Tredaptive therapy plus statin therapy or statin therapy alone. The study found that the addition of Tredaptive did not significantly reduce the risk of coronary deaths, nonfatal heart attacks, strokes

ArQule Inc., of Woburn, Mass., began patient dosing in a Phase I trial with ARQ 087, an oral multikinase inhibitor with pan-FGFR (fibroblast growth factor receptor) activity. The primary objective of the trial is to determine safety, tolerability and the recommended Phase II dose. Patients with metastatic solid tumors who are refractory to available therapies or for whom no standard systemic therapy exists will be enrolled. The number of patients expected to be enrolled will depend on the

ARCA biopharma Inc., of Broomfield, Colo., said a paper published in the European Journal of Heart Failure discusses the post-hoc analyses of data from the Phase III study, designated BEST (Beta-Blocker Evaluation of Survival Trial), testing Gencaro (bucindolo hydrochloride) in heart failure. Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely

Eli Lilly and Co., of Indianapolis, provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase III study of solanezumab in patients with the condition, but other details of the study, which will begin no later than the third quarter of next year, are yet to come.

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, disclosed data from a Phase III study testing Eliquis (apixaban) for the prevention of recurrent venous thromboembolism (VTE). Data from the year-long trial, published in the New England Journal of Medicine, showed that treatment with Eliquis significantly reduced the recurrence of VTE and death from any cause compared to those treated with placebo.

Iroko Pharmaceuticals LLC, of Philadelphia, reported that a Phase III study of submicron indomethacin for postsurgical pain met its primary endpoint of significant pain relief compared to placebo. The trial enrolled 462 patients, who were randomized to submicron indomethacin, celecoxib or placebo. Submicron indomethacin met that goal at all doses tested. The drug was developed using technology licensed to Iroko from iCeutical Pty Ltd., which alters the pharmacokinetic absorption properties of

Isis Pharmaceuticals Inc., of Carlsbad, Calif., reported that three drugs were found to be safe and well tolerated in separate Phase I studies. The drugs, ISIS-PTP1B(Rx), ISIS-GCGR(Rx), and ISIS-GCCR(Rx), are in development for indications related to metabolic disorders including Type II diabetes. ISIS-PTP1B(Rx) is designed to target protein tyrosine phosphatase-1B, ISIS-GCGR(Rx) is designed to target the glucagon receptor and ISIS-GCCR(Rx) is designed to target the glucocorticoid receptor

Johnson & Johnson, of New Brunswick, N.J., reported that galantamine gave a significantly lower mortality rate compared to placebo in a study of patients with severe Alzheimer's disease. The galantamine group also had significantly less cognitive decline after two years compared to the placebo group. The study was terminated early due to an imbalance of deaths between the treatment and placebo group, favoring the treatment group. The study enrolled 2,051 subjects at 127 sites in 13 countries

BrainCells Inc., of San Diego, said it completed a Phase I multiple-ascending-dose study of BCI-838, an oral prodrug of the company's Group II mGluR2/3 antagonist, BCI-632. BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy. The company will advance the compound into a proof-of-concept

Pfizer Inc., of New York, said randomized Phase II data showed that PD-0332991 in combination with letrozole significantly extended progression-free survival (PFS) compared to letrozole alone in postmenopausal women with estrogen receptor-positive human epidermal growth factor receptor-1-negative locally advanced or metastatic breast cancer. Patients in the combination arm showed a median PFS of 26.1 months vs. 7.5 months in the letrozole-only arm, a statistically significant improvement (p < 0

UCB SA, of Brussels, Belgium, said a subgroup analysis of pooled data from three long-term open-label extension trials showed a consistent safety profile with epilepsy drug Vimpat (lacosamide), with the most commonly reported treatment-emergent adverse events being dizziness, headache and nasopharyngitis. Lacosamide exposure also was associated with a reduction in seizure frequency during the study period. A post-hoc analysis of pooled data from three Phase II/III studies suggested a greater

Jazz Pharmaceuticals plc, of Dublin, Ireland, said the first patient was enrolled and dosed in a 25-patient study testing Erwinaze (asparaginase Erwinia chrysanthemi) administered intravenously as an alternative method of administration to treat patients with acute lymphoblastic leukemia with hypersensitivity to E. coli-derived asparaginase therapy. Preliminary pharmacokinetic data are expected in the second half of 2013. NeuroVive Pharmaceutical AB, of Lund, Sweden, said Phase I data

Emmaus Medical Inc., of Torrance, Calif., completed patient enrollment in a Phase III trial of L-glutamine for sickle cell disease. The randomized, double-blind, placebo-controlled trial will assess safety and efficacy of L-glutamine for sickle cell anemia and beta0-thalassemia. The trial has enrolled 225 patients at 31 sites in the U.S. (See BioWorld Today, Oct. 12, 2012.) InnaVirVax, of Evry, France, said interim results of a Phase I/IIa trial showed good safety and tolerability for the VAC

H. Lundbeck A/S, of Copenhagen, Demark, presented three-year vision data at the American Epilepsy Society meeting in San Diego. The FDA requires a risk evaluation and mitigation strategy for Sabril due to the risk of treatment-induced permanent vision loss, and the company offers an ongoing patient registry. Of the total patients enrolled in the registry, 2,676 had infantile spasms and 1,354 had refractory complex partial seizures. Because of the nature of the registry and vision testing

Theravectys SAS, of Paris, was granted authorization by the National Security Agency for Medicines and Health Products in France and the Federal Agency for Medicines and Health Products in Belgium to launch a Phase I/II trial with its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology.

Aduro BioTech Inc., of Berkeley, Calif., said it completed enrollment in a Phase II trial of CRS-207 and GVAX Pancreas Cancer Vaccine eight months ahead of schedule. The vaccine regimen was given to patients with metastatic pancreatic cancer, and it was well tolerated with no unexpected adverse events. An interim analysis of safety and efficacy will be reported in the first quarter of 2013. Ariad Pharmaceuticals Inc., of Cambridge, Mass., published results of a Phase I trial of ponatinib in

Bayer AG, of Leverkusen, Germany, said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete. TRUST is designed to test the recombinant Factor VIIa protein in patients with hemophilia A or hemophilia B who have developed neutralizing antibodies. The study is composed of two parts: The first will involve sequential dose escalation for assessing dose response and

Bayer AG, of Leverkusen, Germany, said results of two pivotal Phase III studies, published in The Lancet, demonstrated the efficacy of regorafenib in patients with metastatic colorectal cancer or gastrointestinal stromal tumor who have exhausted all other treatment options. Data from the CORRECT study showed regorafenib plus best supportive care significantly improved overall survival and progression-free survival compared to placebo plus BSC (6.4 months vs. 5 months and 1.9 months vs. 1.7