U.S. markets closed
  • S&P 500

    +32.40 (+0.88%)
  • Dow 30

    +248.74 (+0.83%)
  • Nasdaq

    +87.05 (+0.70%)
  • Russell 2000

    +43.75 (+2.37%)
  • Crude Oil

    +0.45 (+0.99%)
  • Gold

    +0.90 (+0.05%)
  • Silver

    +0.18 (+0.76%)

    -0.0022 (-0.18%)
  • 10-Yr Bond

    +0.0490 (+5.33%)

    -0.0015 (-0.11%)

    +0.2800 (+0.27%)

    +66.93 (+0.35%)
  • CMC Crypto 200

    -14.05 (-3.71%)
  • FTSE 100

    +59.96 (+0.92%)
  • Nikkei 225

    -58.13 (-0.22%)

Blog Exposure - Avenue Therapeutics Reported Positive Results from Pivotal Phase-3 Trial of IV Tramadol

Stock Monitor: Taro Pharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / May 23, 2018 / If you want access to our free research report on Avenue Therapeutics, Inc. (NASDAQ: ATXI), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ATXI as the Company's latest news hit the wire. On May 21, 2018, the Company announced that its first pivotal Phase-3 trial assessing IV tramadol for treatment of patients with moderate to moderately severe postoperative pain following bunionectomy surgery achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo. Register today and get access to over 1,000 Free Research Reports by joining our site below:


Active-Investors.com is currently working on the research report for Taro Pharmaceutical Industries Ltd (NYSE: TARO), which also belongs to the Healthcare sector as the Company Avenue Therapeutics. Do not miss out and become a member today for free to access this upcoming report at:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Avenue Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


Phase-3 Trial Evaluating IV Tramadol Patients to Begin in Q3 2018

The Phase-3 trial met its key secondary endpoints and demonstrated a clear dose response. The Company plans to initiate a second pivotal Phase-3 trial of IV tramadol in patients following abdominoplasty surgery in Q3 2018.

IV Tramadol was Well-Tolerated with No Reports of Drug-Related Serious Adverse Events

The Phase-3, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 409 patients following bunionectomy surgery. Patients were randomized in a 1:1:1 ratio to a postoperative regimen of 50 mg of IV tramadol, 25 mg of IV tramadol or placebo administered over 15 minutes at hours 0, 2, 4, and once every 4 hours thereafter, for up to 13 doses. The IV tramadol 50 mg treatment arm achieved the primary endpoint of statistically superior improvement in SPID48 compared to placebo. The 50 mg arm also met all three key secondary endpoints. The profile of pain intensity over time demonstrated that IV tramadol 50 mg achieved statistically significant improvement in pain reduction as early as ½ hour after dosing.

IV tramadol was well-tolerated with no reports of drug-related serious adverse events in the trial. The most common adverse events in the trial where IV tramadol 50 mg differed from placebo were nausea, vomiting, dizziness, and somnolence. Detailed trial results will be submitted for presentation at a future scientific conference or for publication in a journal.

Avenue Anticipates Filing an NDA with the US Food and Drug Administration in Late 2019

Lucy Lu, M.D., President and Chief Executive Officer of Avenue, stated that IV tramadol has the potential to provide a convenient bridge to the widely prescribed oral tramadol. This combination could displace Schedule II narcotics altogether for many patients and provide a treatment option with less potential for abuse and a lower risk of dependence.

Lucy added that the Company is happy about these results and looks forward to initiating a second pivotal Phase-3 trial in the third quarter and, assuming positive data from that study and its ongoing safety trial, Avenue anticipates filing an NDA with the US FDA in late 2019.

Post the announcement of the news, shares of the Company surged in pre-market trade.

About IV Tramadol

Tramadol is a synthetic, dual-acting opioid with a unique mechanism of action that delivers opioid efficacy with less potential for abuse and a lower risk of dependence than conventional narcotics. Oral tramadol has a well-established efficacy and safety profile and is currently approved and marketed in the US for moderate to moderately severe pain in adults. There is currently no approved IV formulation in the US.

About Avenue Therapeutics, Inc.

Headquartered in New York City, New York, Avenue Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol for the management of moderate to moderately severe postoperative pain.

Stock Performance Snapshot

May 22, 2018 - At Tuesday's closing bell, Avenue Therapeutics' stock tumbled 12.22%, ending the trading session at $3.59.

Volume traded for the day: 134.26 thousand shares, which was above the 3-month average volume of 38.14 thousand shares.

After yesterday's close, Avenue Therapeutics' market cap was at $37.77 million.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers-Other industry.


Active-Investors (A-I) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. A-I has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

A-I has not been compensated; directly or indirectly; for producing or publishing this document.


The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third-party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email info@active-investors.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by A-I. A-I is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. /p>


A-I, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. A-I, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, A-I, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.


This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither A-I nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://active-investors.com/legal-disclaimer/.


For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: info@active-investors.com
Phone number: 73 29 92 6381
Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Active-Investors