AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported that its Phase II study of sublingual sufentanil NanoTab for acute pain, ARX-04, met its primary endpoint of significantly greater pain reduction than placebo (p = 0.003). Patients who had received bunionectomy surgery were dosed with 30 mcg sufentanil no more than once per hour. Adverse events were mild to moderate, with two severe events (infections) reported, which were determined to be unrelated to the study drug. AcelRx will

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

Ceregene Inc., of San Diego, reported top-line data from its double-blind, randomized, controlled Phase IIb study of CERE-120 (AAV-neurturin), a gene therapy designed to deliver the neurotrophic factor neurturin, for Parkinson's disease. The trial did not demonstrate statistically significant efficacy on the primary endpoint, which was UPDRS-motor off. However, one of the secondary endpoints (Diary-off score), as defined and prespecified in the statistical analysis plan, did produce

Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said its SynCon universal H1N1 influenza vaccine generated protective antibody levels comparable to an FDA-approved seasonal influenza vaccine against a currently circulating flu strain. Data from the Phase I study in healthy volunteers were presented at the World Vaccine Congress in Washington. Northwest Biotherapeutics Inc., of Bethesda, Md., said that a patient treated with DCVax-L for glioblastoma multiforme in 2002 has celebrated his 10th

Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461, a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (p

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

Advanced Cell Technology Inc., of Marlborough, Mass., treated the first patient in patient cohort 2a of its Phase I trials, consisting of patients with better vision, in its U.S. trial for Stargardt's Macular Dystrophy (SMD), a form of juvenile macular degeneration. The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial cells. As the company announced on Jan. 22, patients with a visual acuity of 20/100 are eligible for enrollment in cohort 2a in the

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

Pacira Pharmaceuticals Inc., of Parsippany, N.J., reported Phase IV (EXCLAIM) results for Exparel (bupivacaine liposome injectable suspension) in postsurgical analgesia. Patients who received Exparel after abdominoplasty, breast augmentation, breast reduction or a combination procedure had low pain scores, high satisfaction with their pain control and minimal opioid use. Pacira presented the findings at The Aesthetic Meeting 2013.

Reviva Pharmaceuticals Inc., of San Jose, Calif., reported top-line results from its Phase II REFRESH study of RP5063 in schizophrenia and schizoaffective disorder, with the dopamine serotonin stabilizer showing overall broad efficacy across the Positive and Negative Syndrome Scale total scores, as well as subscales: Positive, Negative and General Psychopathology. RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated. The study enrolled 234 patients

Advanced Cell Technology Inc., of Santa Monica, Calif., treated patients in a third cohort of each of its two Phase I trials of human embryonic stem cell-(hESC) derived retinal pigment epithelial cells for macular degeneration. The patients received 150,000 cells, compared with the 100,000-cell dose used in the second cohort. The trials will assess safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with Stargardt's macular dystrophy and dry age

Anaeropharma Science Inc., of Tokyo, initiated a Phase I trial of APS001F in U.S. patients with advanced or metastatic solid tumors whose disease is no longer responsive to available treatments. The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors. The therapy is expected to limit the systemic toxicity of the antitumor agent 5-FU. Anthera Pharmaceuticals

BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said it started a Phase I trial in healthy volunteers to evaluate orally administered BCX4161 , a selective inhibitor of plasma kallikrein in development for the prevention of attacks in patients with hereditary angioedema. The study is expected to assess safety, characterize plasma drug levels and estimate the extent of kallikrein inhibition achieved. Data are expected later this year. Catabasis Pharmaceuticals Inc., of

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.

Affinium Pharmaceuticals Inc., of Toronto, said its Phase IIa trial evaluating oral AFN-1252 in acute bacterial skin and skin structure infections (ABSSSI) demonstrated efficacy and safety, marking a proof-of-concept milestone for Affinium's first-in-class antibiotic targeted against bacterial fatty acid biosynthesis inhibition. The study in 103 patients confirmed the efficacy, safety and tolerability of 200 mg of oral AFN-1252 dosed twice daily for five to 14 days in patients with ABSSSIs due

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. The data showed that about 45 percent of patients who achieved clearance after the initial two- or three-day treatment experienced sustained clearance of AK lesions a year later. Patients in the overall study

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

Acorda Therapeutics Inc., of Ardsley, N.Y., said data from a Phase I study showed that a single dose of 20-mg Diazepam Nasal Spray had comparable plasma bioavailability to 20 mg of diazepam rectal gel. Diazepam Nasal Spray is being developed for treating people with epilepsy who experience cluster seizures, also known as acute repetitive seizures. Data were presented at the American Academy of Neurology meeting in San Diego. Acorda plans to submit a new drug application under the 505(b)(2

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.