AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies. Naloxegol is a peripherally acting mu-opioid receptor antagonist in development for opioid-induced constipation. Data were presented at the Digestive Disease Week conference in Orlando, Fla. Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported that tiotropium

Destiny Pharma Ltd., of Brighton, UK, reported progress in the Phase I U.S

UCB SA, of Brussels, Belgium, said data from a double-blind, placebo-controlled study found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate to severe restless legs syndrome (RLS)/Willis-Ekbom disease. The data were presented at the annual meeting of the American Society of Hypertension. Results showed that rotigotine

Bayer HealthCare Pharmaceuticals Inc., of Berkeley, Calif., and Onyx Pharmaceuticals Inc., of South San Francisco, said the FDA approved Bayer's Stivarga (regorafenib) for metastatic gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate. Stivarga was previously approved for metastatic colorectal cancer. Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., enrolled their first patients in Phase III COMPARE and ASCERTAIN trials of

Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. Lilly said it will stop development of enzastaurin, a serine/threonine kinase inhibitor of the PKC beta and AKT pathways, and

Eisai Inc., of Woodcliff Lake, N.J., said antiepileptic drug Fycompa (perampanel) showed a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to two new analyses of early clinical experience. Data were presented at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland.

Baxter International Inc., of Deerfield, Ill., said a Phase III study testing immunoglobulin did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. Results, however, showed a positive, numerical difference in the change from baseline vs. placebo in cognition in a subgroup analysis, though the study was not powered to show statistical significance among subgroups. Based on those data, Baxter

Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, said patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the U.S. for the investigational oral Bruton's Tyrosine Kinase inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics Inc., of Sunnyvale, Calif. The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib

Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported positive topline results from AUGMENT COPD, the second six-month pivotal Phase III trial evaluating the efficacy and safety of investigational fixed-dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA), delivered in the Pressair (Genuairn outside the U.S.) inhaler. The 400/12 mcg combination of aclidinium/formoterol demonstrated statistically significant improvements in change from

Pfizer Inc., of New York, said that top-line data for a Phase IV trial of Celebrex (celecoxib) capsules or naproxen in juvenile idiopathic arthritis patients demonstrated no difference in changes to systolic blood pressure, the primary endpoint, and diastolic blood pressure, the secondary endpoint. The safety profile was similar in both groups. Celebrex has been approved by the FDA for juvenile rheumatoid arthritis since 2006, but little is known of the impact of nonsteroidal anti-inflammatory

ADial Pharmaceuticals LLC, of Charlottesville, Va., said the FDA approved its plan to initiate Phase III trials of AD04 in alcohol use disorder in certain targeted genotypes. Patients will initially be screened for the targeted genotypes, and those with one or more of the targeted genotypes will be enrolled in the trial. Enrolled patients will then be randomized between the active drug and placebo. The endpoints for demonstrating the efficacy of AD04 in the trial are percent of heavy drinking

Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported top-line results from a six-month pivotal Phase III study testing fixed-dose combinations of aclidinium bromide, a long-acting muscarinic beta2 agonist, and formoterol fumarate, a long-acting beta2 agonist, delivered using Almirall's inhaler Genuair. Both combinations of aclidinium/formoterol showed statistically significant improvements in the co-primary endpoints of change from baseline in morning predose

Iroko Pharmaceuticals LLC, of Philadelphia, will present positive Phase III data for its nonsteroidal anti-inflammatory drug pipeline at two medical meetings summarizing studies of submicron indomethacin and submicron diclofenac for osteoarthritis pain. Both studies met the primary endpoint of significant pain relief compared to placebo. Data for indomethacin will be presented at the 29th Annual Meeting of the American Academy of Pain Medicine in Fort Lauderdale, Fla. Data for diclofenac will

Phosphagenics Ltd., of Melbourne, Australia, said it achieved all the endpoints of its Phase I trial of its oxymorphone patch by successfully delivering the opioid into the bloodstream via its TPM transdermal patch. The company will proceed with Phase II trials in the second half of 2013.

LEO Pharma UK, of Princes Risborough, UK, reported that data published in the Journal of the American Medical Association Dermatology demonstrated the long-term effectiveness of Picato (ingenol mebutate) in treating actinic keratosis (AK), a leading cause of nonmelanoma skin cancer

Teva Pharmaceutical Industries Ltd., of Jerusalem, and H. Lundbeck A/S, of Copenhagen, Denmark, said the ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), testing Azilect (rasagiline tablets) as an add-on treatment to dopamine agonists compared to placebo met its primary endpoint. Results showed that the addition of Azilect 1 mg/day provided a statistically significant improvement in total Unified Parkinson's Disease Rating Scale score from baseline to week 18 in

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, started a Phase IIIb trial to evaluate the glycemic efficacy and safety of linagliptin in patients with Type II diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio [UACR] 30-3000 mg/g creatinine), while remaining on current standard therapy for diabetic nephropathy.

Eli Lilly and Co., of Indianapolis, presented findings at the European Association of Urology Congress in Milan, Italy, showing that Cialis 5 mg once daily co-administered with finasteride (Proscar, Merck & Co. Inc.) significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride

Merck & Co. Inc., of Whitehouse Station, N.J., said the data safety monitoring board of the IMPROVE-IT trial testing cholesterol-lowering drug Vytorin (ezetimibe/simvastatin) completed its planned review and recommended that the study continue. The study design calls for the collection of 5,250 clinical endpoints, and Merck remains blinded to the actual results of the analysis and to other safety and efficacy data. No additional interim analyses are planned for the 18, 141-patient, event-driven