Forest Labs Announces Positive Topline Phase III Results For Vilazodone; Trevena Announces Positive Phase 1 Results for TRV734 Print E-mail
By Staff and Wire Reports   
Monday, 23 June 2014 18:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 23, 2014.
Forest Laboratories, Inc. (NYSE: FRX) announced positive topline results from three Phase III trials evaluating the efficacy, safety and tolerability of vilazodone in adult patients with generalized anxiety disorder (GAD). In two flexible-dose and one fixed-dose GAD trials, patients who received vilazodone demonstrated statistically significant improvement from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score versus placebo at week 8, the primary endpoint.

“Forest is committed to helping people living with generalized anxiety disorder and other mental health conditions. We have a growing mental health portfolio and are one step closer to one day offering general anxiety patients a new treatment option to help manage this condition,” said Marco Taglietti, M.D., Chief Medical Officer and EVP, Drug Development and Research at Forest Laboratories, Inc.

Based on these results, the Viibryd supplemental New Drug Application (sNDA) for the treatment of GAD will be filed with the FDA in 2015.

About the flexible-dose Phase III Study (MD-07) - This multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week Phase III study evaluated the efficacy, safety, and tolerability of vilazodone as treatment in adult patients with GAD. Eligible patients were those who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for GAD, and had a minimum total score of 20 on the HAM-A scale. Following a 7 day screening period, a total of 415 patients between 18 and 70 years of age were randomized to one of two treatment groups (vilazodone 20 - 40 mg/day, or placebo) followed by a 1-week down-taper safety period. The primary endpoint was defined as change from baseline to end of week 8 in the HAM-A total score. Statistically significant improvement in the HAM-A total score was observed in the vilazodone 20 - 40 mg/day group relative to the placebo group (Least squares mean difference (LSMD): vilazodone 20 - 40 mg/day: -2.2, p=0.0048) using a mixed-effect model for repeated measures (MMRM). Most common adverse events in the vilazodone 20-40 mg/day group (incidence ≥10 % and greater than placebo) were nausea, diarrhea, headache, and dizziness.


Trevena, Inc. (NASDAQ: TRVN) announced positive results from its Phase 1 trial of TRV734, which Trevena is developing with the goal of providing improved analgesia while avoiding gastrointestinal and respiratory side effects typically associated with opioids. The study tested single ascending doses and the relative bioavailability of oral TRV734 in healthy subjects, and demonstrated that TRV734 is pharmacologically active at a range of safe and well-tolerated doses. The data suggest that TRV734 provides dose-related exposure, speed of onset, and duration of action suitable for treating moderate-to-severe acute pain.

"This trial showed that TRV734 is orally bioavailable and produces central nervous system activity consistent with analgesia, at doses that are safe and generally well-tolerated," said David Soergel, M.D., senior vice president, clinical development. "We identified an active dose range that was very well tolerated, supporting our belief that TRV734 could present a superior therapeutic profile compared to currently prescribed opioids."

Highlights of the two-part trial involving a total of 76 healthy subjects include:
  • Dose-related increases in plasma concentrations, with peak plasma concentrations reached approximately one hour after dosing and a terminal half life consistent with use for treating acute pain
  • Pupil constriction indicative of analgesia observed at doses of 80 mg and higher, and mild-to-moderate adverse effects reported at the maximum explored dose of 250 mg. This suggests that the analgesic efficacy of TRV734 may be separable from opioid-related adverse effects
  • No clinically significant changes in vital signs, laboratory values or ECG parameters, and no severe or serious adverse events reported

"These results are highly encouraging and provide a path towards Phase 2 clinical studies of this molecule," said Maxine Gowen, Ph.D., president and chief executive officer. "In addition, the data further validate the shared mechanism of action of TRV734 and TRV130, and underscore the potential for these agents to provide prescribers and patients with new and differentiated treatment options in both hospital and outpatient settings."

Phase 1 trial of TRV734 -- This study was a two-part first-in-human trial and was designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TRV734. Part A assessed single ascending doses of TRV734 in 64 healthy male subjects. The potentially efficacious dose range of TRV734 was evaluated using pupillometry, a validated biomarker for mu-opioid receptor engagement in the central nervous system that correlates with analgesic efficacy. Cohorts of eight subjects were randomized to receive a single dose of up to 250 mg of TRV734 or placebo. Part B of the study was a randomized, open-label, three-period crossover study of single 125 mg doses of TRV734 in 12 healthy male subjects, designed to compare the PK and PD of an oral capsule and oral solution, each administered after a fast, and an oral capsule when administered after a high-fat meal.

About TRV734 -- The mu-opioid receptor is a well-established target for effective analgesics such as fentanyl and morphine, which are unbiased mu-opioid agonists. TRV734 is a biased ligand at the mu-opioid receptor, activating the G protein pathway, associated with analgesia, without activating the mu-opioid beta-arrestin pathway, associated with respiratory depression and constipation in preclinical studies. TRV734 takes advantage of the same novel biased ligand mechanism at the mu-opioid receptor as TRV130, the company's Phase 2 intravenous clinical candidate which has shown promising differentiation vs. morphine.

Also Monday: 

Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced it has been awarded an Information Technology Equipment Schedule 70 contract by the U.S. General Services Administration (GSA), the procurement arm of the Federal government.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that Dr. Linda Marbán, President and CEO, will present during a panel at the first, all-day Regenerative Medicine Forum organized by the California Institute for Regenerative Medicine (CIRM), in association with the Alliance for Regenerative Medicine (ARM) and the International Society for Stem Cell Research (ISSCR).

Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today the launch of Omega PC™, a new, premium fish oil-based omega-3 product.

Hemp, Inc.'s (OTC:HEMP) wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc. (IHMMCC), announced today that it has signed a consultant agreement with PPJ Enterprise (OTC:PPJE), a leader in medical practice information management.

MedAssets (Nasdaq:MDAS) unveiled the upgraded version of Decision Support Costing and Contracting, a business intelligence tool that combines clinical, operational and financial system data from across care settings.

Praxsyn Corporation (OTCQB:PAWS), a medication and service provider for medical practitioners, announced that it is making progress in filing its Form 10-Q for the quarter ended March 31, 2014.

Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today that it has commenced an underwritten public offering of $100 million of its ordinary shares.

RedChip Companies, Inc., announced it has issued a research profile on SANUWAVE Health, Inc. (OTCQB:SNWV), a shock wave technology company focused on the development and commercialization of patented non-invasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures.

Signal Genetics, Inc. (Nasdaq:SGNL), a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the closing of its previously announced initial public offering of 850,000 shares of its common stock at a price to the public of $10.00 per share.

The Special Committee of SWK Holdings Corporation (OTCBB:SWKH), a life science focused specialty finance company, issued the following statement regarding Carlson Capital's letter to the Special Committee dated June 20, 2014:  "In response to Carlson Capital's May 16, 2014 proposal to acquire 80 million shares of newly issued common stock of the Company at a price of $1.20 per share, the Special Committee has been considering a range of debt and equity financing alternatives with the objective of ensuring that the financing transaction ultimately pursued by the Company is in the best interests of all stockholders of the Company.

Versartis, Inc. (Nasdaq:VSAR)
, an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today presented positive Phase 2a data from its six month clinical trial demonstrating the safety and efficacy of VRS-317 in the treatment of naïve, pre-pubertal children with growth hormone deficiency (GHD).

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