Avenue Therapeutics is dedicated to developing innovative therapies aimed at addressing neurologic diseases, with a focus on creating impactful treatment options that can significantly improve patient outcomes. The company is advancing a diverse portfolio of therapies, which includes both first-in-class and best-in-class programs. This strategic approach is designed to tackle the significant unmet needs within the neurologic landscape, where existing treatment options may fall short.

The company's commitment to innovation is reflected in its unique pipeline of therapies, which are positioned to overcome the limitations of current treatments. Avenue Therapeutics aims to transform the standard of care for patients suffering from neurologic conditions by leveraging its expertise in specialty pharmaceuticals to bring forward novel solutions that can enhance the quality of life for these individuals.

United States

Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO).
FBIO owns a controlling number of voting shares of ATXI. Invagen entered an agreement to purchase ATXI if certain conditions are met, including approval of IV tramadol before April 30, 2021, but Invagen has indicated that due to the Covid epidemic, it can terminate its purchase agreement to acquire ATXI.

Central Nervous System (CNS)

Nervous System Diseases

Pathological Conditions

Avenue Therapeutics

Pain

Post operative acute pain

Tramadol is a centrally-acting, atypical opioid analgesic with a dual mechanism of action. It is an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake. The analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin. Opioid activity is due to both low-affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors.1 Tramadol has been noted to have a low risk of abuse compared to conventional opioids such as morphine2,3 and is a Schedule IV controlled substance in the US The Drug Enforcement Administration (DEA) scheduling criteria indicate that Schedule IV drugs have a low potential for abuse and low risk of dependence.4 This contrasts with conventional opioids (Schedule II drugs) that have a high potential for abuse. The scheduling difference reflects the understanding that tramadol, as an atypical opioid with dual mechanism of action, does not carry the same abuse potential as Schedule II opioids.2 (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250287/">SOURCE</a>)
 
"Parenteral tramadol is approved and used for the management of postoperative acute pain throughout much of the world. Parenteral formulations include IV, intramuscular, or IM, and subcutaneous, or SC, formulations. Based on our review of IMS Health data from 2014 to 2016, we believe that parenteral tramadol accounts for approximately 10% of the total IV analgesics used in Europe. During the 10-year period from 2010 to 2019, approximately 370 million doses of parenteral tramadol was used in Europe, according to data from IQVIA (a 3rd party data provider). There is no parenteral formulation currently approved in the United States.
We believe that the introduction of an IV formulation of tramadol in the United States will address many of the shortcomings of opioids, APAP and NSAIDs currently used in the postoperative setting.
We administered IV Tramadol over approximately 15 minutes in our Phase 3 trials. We believe that our method of administration of IV Tramadol may provide significant benefits such as reduced side effects, compared to previously approved methods of administration of IV Tramadol in Europe, which is typically accomplished via a slow push over 2 to 3 minutes. In addition, our IV Tramadol dosing regimen produces a similar Cmax (maximal blood level) and AUC (overall systemic exposure) to those of oral tramadol at steady state, which we believe ensures an easy transition from IV to oral therapy in the post-surgical setting.
Based on the trials done in Europe and on the data generated with oral tramadol, we believe that IV Tramadol, if approved, will be an attractive option for physicians who treat postoperative pain in the U.S., due to the following attributes:
&nbsp;&nbsp;&nbsp;&nbsp;• As an established analgesic, tramadol has documented efficacy and safety and physicians are already familiar with the drug.
&nbsp;&nbsp;&nbsp;&nbsp;• As a Schedule IV controlled substance, tramadol has less potential for addiction and abuse than other narcotics widely prescribed in the post-surgical setting. In the current environment where the opioid epidemic is a recognized problem in the United States and there are increasing restrictions on Schedule II opioids, a Schedule IV opioid such as tramadol may become a more attractive option.
&nbsp;&nbsp;&nbsp;&nbsp;• Importantly, there is a step-down therapy available for IV Tramadol. Patients are transitioned to oral therapy when they are discharged from the hospital or when they can tolerate oral medicine. Our IV Tramadol dosing regimen provides a similar PK profile to that of oral tramadol at steady state to ensure a smooth step-down process.
 
We believe that IV Tramadol, if approved, will be a useful and effective tool in the management of acute postoperative pain. Its potential advantages compared to current standard-of-care agents, along with the known efficacy, safety and tolerability profile for oral tramadol support the use of IV Tramadol in this setting. We believe that the risks associated with the use of IV Tramadol will be benign compared to other opioids, and consistent with that of the currently marketed oral tramadol products. Consequently, with the industry trend toward multimodal therapy and away from Schedule II narcotics, we believe that, if approved, IV Tramadol’s unique profile could position it to become an invaluable part of a treating physician’s repertoire of available pharmaceutical options in the management of postoperative pain."&nbsp;
<a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1644963/000110465921044358/tm2140561_10k.htm#a_002">SOURCE</a>

IV Tramadol

Anxiety Disorders

Epilepsy

BAER-101 is a positive allosteric modulator (PAM) of α2,3 subunit‐containing GABAA&nbsp;receptors with minimal activity at α1 or α5‐containing receptors, which are believed to mediate many of the issues impacting the medical use of benzodiazepines such as those noted with diazepam use (tolerance, dependence, abuse, sedation, impaired cognition). As a result, BAER-101 may have potential to treat epilepsy, anxiety, and other disorders in which benzodiazepines are currently used, while minimizing the benzodiazepine associated adverse effects. BAER-101 was licensed from Astra Zeneca with a large safety database in over 700 patients and an efficacy signal in a subset of patients with anxiety.

Avenue Therapeutics

Company Details