|FDA Issues Complete Response Letter for PLUMIAZ™; Trevena Presents Results from Phase 1b Trial of TRV130|
|By Mary Davila|
|Friday, 02 May 2014 20:09|
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZTM (diazepam) Nasal Spray for the treatment of people with epilepsy who experience cluster seizures.
A CRL is a communication from the FDA that informs a company that their review of the NDA is complete and the application cannot be approved in its present form. The Company is currently developing a response to address the items outlined in the letter.
“There is an urgent need for new treatments for people with epilepsy who experience cluster seizures. We are committed to the development and commercialization of PLUMIAZ, a potential therapeutic option for these individuals,” said Ron Cohen, M.D., Acorda’s President and CEO. “We are evaluating the Complete Response Letter and expect to work closely with the FDA to address the items outlined in the letter and refile the NDA for PLUMIAZ. We expect to provide further detail as our discussions with the FDA progress.”
Based on the requirements for approval outlined in the letter, the Company does not expect PLUMIAZ to receive FDA approval in 2014.
Of the approximately 2.8 million people in the United States with epilepsy, it is estimated that about 175,000 experience cluster seizures, also known as acute repetitive seizures or bouts of increased seizure activity. These patients may experience cluster seizures even though they generally are on stable regimens of antiepileptic medications (AEDs). Currently, many of these individuals do not find the currently available outpatient therapy acceptable and default to emergency room care or no care at all. PLUMIAZ potentially offers a more viable treatment option. PLUMIAZ has received orphan drug designation for the treatment of cluster seizures.
Trevena, Inc. (NASDAQ: TRVN), a clinical stage pharmaceutical company focused on the discovery and development of G protein coupled receptor (GPCR) biased ligands, announced that data from the Company’s Phase 1b trial of TRV130, a small molecule G protein biased ligand at the mu-opioid receptor, are being presented today in a poster session at the American Pain Society Annual Meeting in Tampa, Florida. In the study, TRV130 was generally well tolerated and produced greater analgesia compared to morphine with less reduction in respiratory drive, less vomiting, and less severe nausea in healthy subjects. TRV130 is in development as a first-line treatment for patients experiencing moderate to severe acute pain where intravenous administration is preferred.
“The data to be presented today provide early proof-of-concept for TRV130, suggesting that when compared directly to morphine, the biased ligand’s selective signaling may allow for better pain control, with less of the dose-limiting adverse events associated with current opioid treatments,” stated David Soergel, M.D., senior vice president, clinical development at Trevena. “These results suggest that TRV130 could be a meaningful advance in the treatment of pain after surgery and provide a strong rationale for continued development.”
The results will be presented in a poster entitled, “TRV130, a novel biased opioid ligand, elicits increased analgesia with reduced adverse effects compared to morphine in healthy volunteers.” The randomized, double-blind, placebo-controlled, 5-period crossover study enrolled 30 healthy adult males. Subjects were administered 1 of 5 treatments in each period: 1.5 mg, 3.0 mg, or 4.5 mg of TRV130 via intravenous administration, 10 mg morphine or placebo. The objectives of the trial were to evaluate the safety and tolerability of TRV130, the analgesic effects of TRV130 using the cold pain test vs. placebo, compare TRV130 to morphine and to placebo, evaluate the pharmacokinetics of TRV130 and evaluate the effect of TRV130 on responses to the Drug Effect Questionnaire.
As measured by the cold pain test, TRV130 at 3 mg and 4.5 mg increased analgesia with a more rapid onset of action, superior analgesic effect, and similar duration of action compared with 10 mg morphine. In addition, at the 3 mg and 4.5 mg TRV130 doses, more subjects doubled baseline cold pain test latency and achieved maximum cold pain test latency of 180 seconds. In addition to increased cold pain test efficacy, TRV130 produced less reduction in respiratory drive as compared to morphine, as measured by the ventilatory response to hypercapnia.
“The impressive results of this trial demonstrate the clinical translation of our proprietary biased ligand platform into a potential new and differentiated pharmacotherapy for the treatment of moderate to severe, acute postoperative pain,” stated Maxine Gowen, Ph.D., chief executive officer of Trevena. “Based on this strong data set, we are advancing the development of this program. We recently initiated a Phase 2a/b trial of TRV130 in bunionectomy patients, and plan to launch a second Phase 2 trial of TRV130 in soft tissue surgery patients in the fourth quarter of this year.”
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Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that Guo-jie Ye, Ph. D., Director, Research and Pre-Clinical Studies, will present preclinical data related to the company's achromatopsia gene therapy program in an oral session at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting.
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Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that Anthony Marucci, President and Chief Executive Officer, will present a corporate overview at the Deutsche Bank 39th Annual Healthcare Conference on Wednesday, May 7, 2014 at 11:20 a.m. ET at the InterContinental Hotel in Boston and at the Bank of America Merrill Lynch 2014 Healthcare Conference on Wednesday, May 14, 2014 at 4:20 p.m. PT at the Encore at the Wynn in Las Vegas.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that John McDermott, Chairman and Chief Executive Officer, and Shelley Thunen, Chief Financial Officer, are scheduled to participate at two investor conferences in May.
Endocyte, Inc. (Nasdaq:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the first quarter ending March 31, 2014, and provided a clinical update.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign(TM) group of skilled nursing, rehabilitative care services, assisted living, home health and hospice care and urgent care companies, announced today that it expects to issue its first quarter 2014 financial results on Thursday, May 8, 2014.
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Immunomedics, Inc., (Nasdaq:IMMU) today announced the pricing of an underwritten public offering of 9 million shares of its common stock, offered at a price to the public of $3.35 per share.
Intuitive Surgical, Inc. (Nasdaq:ISRG), the industry leader in robotic-assisted surgery, today announced that it has entered into an accelerated share repurchase program (the "ASR Program") with Goldman, Sachs & Co., ("Goldman") pursuant to which Intuitive Surgical will repurchase $1 billion of its common stock from Goldman.
MedAssets (Nasdaq:MDAS) today announced that it will participate in two investment conferences during the month of May.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, will present its approach to designing novel therapeutics by applying site-specific sialylation to Fc glycans in IVIg, monoclonal antibodies, and other recombinant Fc-containing proteins, in a presentation entitled "Embracing Complexity: Understanding IVIg to Rationally Engineer Novel Therapeutics".
Ocera Therapeutics (Nasdaq:OCRX) today announced that Gaurav Aggarwal, M.D., has joined the Company as its Chief Business Officer.
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