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Avenue Therapeutics Submits New Drug Application for IV Tramadol

19 Dec Avenue Therapeutics Submits New Drug Application for IV Tramadol

Avenue Therapeutics (NASDAQ: ATXI), a subsidiary of Fortress Biotech Inc, announced the submission of a New Drug Application (NDA) to the FDA, for IV tramadol, an intravenous solution intended for the treatment of moderate to moderately severe pain in adults. The Company is focused on the development of IV tramadol, which is a synthetic dual-acting opioid in a parenteral formulation that addresses the need for an intravenous dosage of tramadol in the postoperative setting.

The Company has submitted the application based on positive results from two crucial phase 3 trials that evaluated the safety and efficacy of IV tramadol in patients following bunionectomy and abdominoplasty surgeries, besides an open-label safety study with more than 500 patients who received the IV tramadol 50 mg dosing regimen. The submission also includes an epidemiology study on the abuse potential of tramadol in the U.S and the lower incidences of abuse of tramadol via injection compared to oral tramadol.

Lucy Lu, M.D., Avenue’s President and Chief Executive Officer, opines

“As a potential alternative that could reduce the use of conventional opioids, IV tramadol may fill a gap between IV acetaminophen/NSAIDs and IV conventional narcotics in the acute pain space. The submission of this NDA is an important milestone for our company, and we look forward to working closely with the FDA during the review process.”

The Company has entered into an acquisition agreement with InvaGen, a subsidiary of Cipla Limited, whereby Invagen acquired a 33.3% stake in Avenue on a fully diluted basis in February 2019. The second stage closing is pending, subject to approval from FDA, labeling and scheduling and absence of any Risk Evaluation and Mitigation Strategy or similar restrictions in effect with respect to IV tramadol as per a Company statement.

Avenue Therapeutics (NASDAQ: ATXI)

Market Cap: $122M; Current Share Price: 7.39 USDChart
Data by YCharts

Chronic Pain is the leading cause for seeking medical aid in the U.S.A study undertaken by the Centres for disease control and prevention (CDC) in conjunction with NIH and other entities titled “Morbidity and Mortality Weekly Report (MMWR)”in the year 2016, estimates that 20.4% percent of the adults population in the U.S suffered from chronic pain, while 8 percent had high-impact chronic pain limiting at least one important activity in their daily life. Untreated or undertreated chronic pain contributes to$560 billion each year in direct medical costs, lost productivity, and disability programs in the U.S alone.

The global analgesic market is poised to amass $ 26.4 billion by 2022 , growing at a CAGR of 7.1% during 2015 – 2022, according to a report titled “Analgesics Market by Type (Non-opioids, Opioids) and Route of Administration (Oral, Intravenous, Rectal, Transdermal, Topical) – Global Opportunity Analysis and Industry Forecast, 2015 – 2022” published by alliedmarketresearch.

The Analgesic market is broadly divided into Opioid and Non-Opioid therapeutics. Opioid based medicine has given rise to an addiction endemic with prescription drug overdose becoming one of the leading causes of preventable deaths in the U.S in turn prompting the government to declare a public health emergency in 2017.

An increase in the geriatric population along with a rise in life-style related ailments and chronic diseases will drive the growth in the non-opioid market, along with a favourable government and regulatory environment, increased spending on research and development and fast track approvals for breakthroughs.

Avenue Therapeutics is a specialty pharmaceutical Company that is a subsidiary of Fortress Biotech (NASDAQ: FBIO), and engaged in the development, acquisition and commercialization of pharmaceutical and biotechnology products in a hospital setting. The Company’s sole focus currently is IV tramadol, an intravenous, or IV, formulation of tramadol HCl, for the management of moderate to moderately severe postoperative pain in a hospital setting. The drug has an established safety and tolerability profile and has been used in the oral from in the U.S and throughout the world for more than 30 years.

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The drug works by blocking the transmission of pain signals to the spine and brain both, offering a dual mechanism of action. This offers a much needed alternative for those who cannot tolerate schedule II narcotics and offers a much lower potential for abuse and lower risk of dependence as well.

IV tramadol has successfully completed phase 3 clinical trials in the field of bunionectomy (an orthopedic model), a study in abdominoplasty (a soft-tissue model) and an open-label study as per a Company statement. The phase 3 study was a multicenter, randomized, double-blind, placebo-controlled trial with a subject size of 370 patients following abdominoplasty surgery, and demonstrated 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, as well as met all of its key secondary endpoints such as tolerability, safety and no adverse events.

Lucy Lu, M.D., Avenue’s President and Chief Executive Officer, commented

“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.”

Risk Assessment

  • The Company’s agreement with Invagen, a subsidiary of CIPLA, will offer its stability, research, development and commercialization support and guidance to navigate regulatory framework.
  • IV Tramadol addresses a very significant need for an intravenous Schedule IV opioid in the U.S. Its dual mechanism of action offers less abuse potential and risk of dependence, which is the need of the hour owing to the growing opioid epidemic in the U.S
  • Avenue has a robust intellectual rights portfolio which gives protection to its proprietary dosing regimen until 2036 in the U.S market.
  • A diverse pipeline of candidates is essential to mitigate risks associated with clinical trials. The Company has only one candidate in its pipeline and it would be interesting to see what its potential new target indication would be.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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