Friday, May 13, 2016 11:04:05 AM
Trevena : Announces Successful End-of-Phase 2 Meeting with FDA and Outlines Phase 3 Program for Oliceridine
05/12/2016 | 05:13pm EDT
By a News Reporter-Staff News Editor at Clinical Trials Week --
Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, announced the successful completion of the End-of-Phase 2 Meeting process with the United States Food and Drug Administration (FDA). The company has reached general agreement with the FDA on key elements of the Phase 3 program to support a New Drug Application (NDA) for oliceridine (TRV130), to which the FDA has granted Breakthrough Therapy designation (see also Trevena, Inc.).
"We are very pleased with the outcome of our End-of-Phase 2 discussion with the FDA," said Maxine Gowen, Ph.D., chief executive officer. "We appreciate the valuable guidance the FDA has provided, and look forward to continuing a constructive relationship as we advance our Phase 3 registration program. We remain focused on bringing oliceridine to market as a new and potentially differentiated analgesic for patients and caregivers seeking alternatives to conventional opioids." End-of-Phase 2 meeting The FDA agreed that pivotal efficacy trials in bunionectomy and abdominoplasty patients include appropriate patient populations to support an indication for moderate to severe acute pain. The agency also confirmed the need for at least 1,100 patients exposed to oliceridine across the development program for the purposes of evaluating safety and tolerability. This database should include a sufficient number of patients with higher exposures and longer durations of oliceridine therapy. In addition, general agreement was reached on the company's planned clinical, nonclinical, clinical pharmacology, and chemistry, manufacturing and control (CMC) activities to support the planned NDA. Overview of the Oliceridine Phase 3 program The oliceridine Phase 3 program includes two pivotal efficacy trials evaluating moderate-to-severe acute pain: the APOLLO-1 study will evaluate pain for 48 hours following bunionectomy, and the APOLLO-2 study will evaluate pain for 24 hours following abdominoplasty. In each trial, patients will be randomized to receive placebo, morphine, or one of three regimens of oliceridine by patient-controlled analgesia (PCA) for the management of their post-operative pain. Each study will enroll approximately 375 patients, allocated equally across study arms.
The primary endpoint for both APOLLO studies will be a responder analysis proposed by the company comparing active treatment arms to placebo. A responder is defined as a patient experiencing a sum of pain intensity difference (SPID) at the end of the treatment period that corresponds to at least a 30% improvement from baseline without early discontinuation and without rescue pain medication.
Secondary endpoints in both APOLLO studies will include comparisons of oliceridine efficacy, safety, and tolerability to morphine. A respiratory safety endpoint will measure prevalence and duration of hypoventilation, which will be a clinical assessment as in the company's Phase 2b abdominoplasty study.
The APOLLO study designs were informed in part by the company's Phase 2b abdominoplasty study, which also used PCA dosing. Powering assumptions included similar performance of PCA-administered oliceridine in both APOLLO studies as was observed in the Phase 2b study. In a post-hoc evaluation using the Phase 3 responder analysis, both doses in the company's Phase 2b study in abdominoplasty yielded analgesic efficacy similar to morphine, and significantly higher than placebo (p = 0.0005 for both oliceridine treatment arms). In addition, using the Phase 3 respiratory safety endpoint, both doses in the company's Phase 2b study showed significantly less respiratory safety burden for oliceridine than morphine (p = 0.0003 for both oliceridine treatment arms).
The development program will include at least 1,100 patients exposed to oliceridine. The on-going open-label ATHENA-1 safety study is enrolling patients experiencing pain as a result of either a medical diagnosis or surgery. In this study, patients may receive oliceridine as-needed either as an intermittent bolus or via PCA device, with doses and durations appropriate to manage their pain.
Both APOLLO-1 and APOLLO-2 are expected to start in the second quarter of this year, and the company expects to report top-line data in the first quarter of 2017. The company continues to expect to file an NDA for oliceridine in the second half of 2017. The company also continues to expect that its available cash and investments will be sufficient to fund operations into 2018. Conference Call and Webcast The company will host a conference call and webcast to discuss its Phase 3 plans. The webcast will be available for replay for 30 days.
Keywords for this news article include: Analgesics, FDA Actions, Trevena Inc, Pain Medicine, Clinical Trials and Studies, Government Agencies Offices and Entities.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2016, NewsRx LLC
(c) 2016 NewsRx LLC, source Health Newsletters
_______________________________________
TRVN
Recent TRVN News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/17/2024 10:36:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/17/2024 10:31:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/30/2024 11:05:21 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 08:06:19 PM
- Trevena Announces Reverse Stock Split • GlobeNewswire Inc. • 08/08/2024 08:05:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/08/2024 11:15:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 11:05:39 AM
- Trevena Reports Second Quarter 2024 Results and Provides Business Update • GlobeNewswire Inc. • 08/08/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 01:16:34 PM
- Trevena Announces $2M Non-Dilutive Financing Tranche and Reduction in Outstanding Liabilities in Connection with Existing ex-US Royalty Financing • GlobeNewswire Inc. • 07/08/2024 01:15:00 PM
- Trevena Announces Preclinical TRV045 Data Providing Insight Into Novel Mechanism of Analgesic Effect in Chronic Neuropathic Pain Model and Demonstrating Statistically Significant Anti-Seizure Activity in Epilepsy Models • GlobeNewswire Inc. • 06/20/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/18/2024 08:43:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 09:06:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:40:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:40:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:39:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:38:37 PM
- Form DEFR14A - Revised definitive proxy soliciting materials • Edgar (US Regulatory) • 05/17/2024 08:05:39 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 11:15:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 11:05:42 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 10:00:24 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 02/20/2024 09:06:01 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 07:34:30 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/09/2024 09:05:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 12:05:28 PM
FEATURED Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM
North Bay Resources Announces Mt. Vernon Gold Mine Bulk Sample, Sierra County, California • NBRI • Sep 11, 2024 9:15 AM
One World Products Issues Shareholder Update Letter • OWPC • Sep 11, 2024 7:27 AM
Kona Gold Beverage Inc. Reports $1.225 Million in Revenue and $133,000 Net Profit for the Quarter • KGKG • Sep 10, 2024 1:30 PM