Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us    
Google
Web www.equitybulls.com
Stock Report

| More

Avenue Therapeutics announces Positive Topline Data from Second Pivotal Phase 3 Study of IV Tramadol

Posted On: 2019-06-04 12:16:23

Avenue Therapeutics, Inc. (NASDAQ: ATXI) ("Avenue"), a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol, today announced that its second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 24 hours (SPID24) compared to placebo in patients with postoperative pain following abdominoplasty surgery. In addition, the trial met all of its key secondary endpoints. The study also includes a standardof-care IV opioid as an active comparator: IV morphine 4 mg. In this study, IV tramadol also demonstrated similar efficacy and safety to that of IV morphine.

"The strong safety and efficacy results from this second Phase 3 trial are consistent with those from the first Phase 3 trial in bunionectomy surgery and demonstrated the utility of IV tramadol in post-surgical pain management regardless of the surgery type," said Lucy Lu, M.D., Avenue's President and Chief Executive Officer. "This study is a significant milestone for Avenue because it brings us one step closer to submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), currently planned for year-end 2019."

"IV tramadol may fill a gap between non-opioid medicine and Schedule II opioids in the post-surgical setting and has the potential to provide a convenient bridge to the widely prescribed oral tramadol, a Schedule IV opioid," said Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research and a thought leader of acute pain trials. "The results from the study demonstrated that IV tramadol is similarly potent to a conventional opioid in patients with post-surgical pain, and therefore, it could be a very important addition to the post-surgical pain armamentarium."

"We are pleased with these results," said Dr. Jaideep Gogtay, Chief Medical Officer at Cipla Limited and a board member of Avenue. "We look forward to working with Avenue in bringing a new and useful therapeutic option to U.S. patients suffering from acute pain."

Phase 3 Trial Design and Results

The Phase 3 multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 370 patients following abdominoplasty surgery. Patients were randomized in a 3:3:2 ratio to a postoperative regimen of 50 mg of IV tramadol, placebo, or 4 mg of IV morphine at hours 0, 2, 4 and once every 4 hours thereafter, respectively, for up to 13 doses over the course of 48 hours. Morphine, a standard-of-care analgesic, was included to obtain comparative safety data versus IV Tramadol.

The primary efficacy endpoint of the study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID24. The key secondary efficacy endpoints included Patient Global Assessment at 24 hours (PGA 24), SPID48, and total consumption of rescue medicine through 24 hours. A key safety objective of the study was to compare the safety and tolerability of IV tramadol to IV morphine.

IV tramadol 50 mg achieved the primary endpoint of statistically superior improvement in pain relief as measured by the SPID24 (p<0.001) compared to placebo, as well as met all three key secondary endpoints (each statistically significant at p < 0.001). IV tramadol and IV morphine demonstrated similar efficacy benefits in the study.

Shares of CIPLA LTD. was last trading in BSE at Rs.569.9 as compared to the previous close of Rs. 559.1. The total number of shares traded during the day was 38832 in over 771 trades.

The stock hit an intraday high of Rs. 569.9 and intraday low of 552.85. The net turnover during the day was Rs. 21874709.


Source: Equity Bulls

Click here to send ur comments or to feedback@equitybulls.com





Other Headlines:

Asian Granito in Fortune India's List as one of The Next Fortune 500 companies

Pantaloons Celebrates the Pujo Rockstars this Pujo with its new campaign

Indian Overseas Bank celebrates Hindi Month - 2019

Alkem Laboratories Ltd acquires undertaking from subsidiary

Sakthi Sugars Ltd agrees for OTS with Bank of India

Pidilite Industries Ltd forms subsidiary

Corporate Tax reduction - Mr. Kamlesh Patel, Chairman and Managing Director - Asian Granito India Ltd

Seamec Ltd announces extension of long term charter for SEAMEC II with HAL Offshore Ltd

Nippon Express to Acquire 22% Stake in Future Supply Chain Solutions Ltd

Hexaware's Salesforce practice has been awarded Gold Consulting Partner status

Lupin receives sANDA approval from U.S. FDA for Levothyroxine Sodium Tablets USP to be considered AB rated to Reference Listed Drug, UNITHROID®

USFDA approval for Unichem Laboratories Ltd's plant at Kolhapur

Zensar Recognized in the 2019 Gartner Magic Quadrant for Data Center Outsourcing and Hybrid Infrastructure Managed Services, North America

Asian Paints launches 'AP Homes' in Bengaluru, its state-of-the-art multi-category décor showroom

Allahabad Bank Introduces External Benchmark Linked Loans under Retail and Micro & Small Enterprises

IndiGo inaugurates flights between India and Myanmar

Strides Board approves incremental investments in Stelis

Himatsingka Seide Ltd board approves investment of Rs. 17.34 crore in wind power SPVs

AXIS Bank Ltd board to consider Q2 results on Oct 21, 2019

Bingo! Pujo Tadka enlivens the festive spirit of Durga Pujo

Just Launched: Official App for TCS Lidingöloppet 2019 Packed with Exciting New Features

Raksha Mantri inaugurates Engineers Conclave (2019), Product Development & Innovation Centre of BEL

Redington offering the latest products from Apple, including iPhone 11 Pro and iPhone 11 Pro Max

Dilip Buildcon Ltd completes road project in Punjab

Anuh Pharma Ltd successfully completes USFDA inspection

Bajaj Electricals Limited receives 2019 ASCM Corporate Award of Excellence for Advance Supply Chain Industry

Brickwork Ratings downgrades rating of Reliance Home Finance Ltd

Morgan Credits Private Limited has sold 2.3% stake in YES Bank Ltd

AXIS Bank opens QIP, fixes floor price as Rs. 661.50

Lux Industries Limited issues CPs of Rs. 50 crore

Godrej Consumer Products Ltd increases stake in subsidiaries

ICRA reaffirms ratings of Reliance Chemotex Industries Ltd

Lincoln Pharmaceuticals Ltd board approves merger of Lincoln Parenteral Ltd

Thyrocare Technologies Ltd calls for board meeting on Sep 21, 2019

Capital India Finance Ltd inks MOU with Union Bank of India for Loan Co-origination

Morepen Laboratories Ltd board approves preferential issue

Mahindra BAJA SAEINDIA 2020 Commences its 13th edition

NMDC revises prices of Iron Ore w.e.f. 19-09-2019

Speedcast and Nelco Awarded Remote Communications Contract for Leading Indian Cruise Line

Bharat Forge Ltd acquisition update regarding Refu Drive GmbH

Kolte-Patil Developers delivers strong returns to Motilal Oswal Real Estate from its City Avenue Project

Astral Poly Technik Limited allots 3,01,32,441 bonus shares

Surya Roshni Ltd bags order of Rs.79.80 crore

TCS a Leader in Software Product Engineering Services: Everest Group

Thomas Cook India observes an impressive 21% growth in demand during Durga Puja

Now buy Detel TVs and connected essentials in IndiGo flights

TVS Motor Company launches TVS NTORQ 125 Race Edition

IDBI Bank board approves preferential issue to Government and LIC

1 millionth Maruti Suzuki car exported from Gujarat's Mundra Port

Mindtree Opens New European Headquarters in London







Website Created & Maintained by : Chennai Scripts
West Mambalam, Chennai - 600 033,
Tamil Nadu, India

disclaimer copyright © 2005 - 2019