BARDA and Enalare partner to reformulate drug for emergency treatment of OIRD

BARDA and Enalare partner to reformulate drug for emergency treatment of OIRD

April 28, 2021

The Biomedical Advanced Research and Development Authority (BARDA) and Enalare Therapeutics have partnered to reformulate the company's respirator stimulant drug ENA-001 for use as an emergency treatment against opioid-induced respiratory depression (OIRD).

Respiratory depression is a condition characterized by slow and ineffective breathing (hypoventilation) that can result in low levels of oxygen and high levels of carbon dioxide and can be life-threatening if left untreated. OIRD can occur after the use of opioid analgesics and can progress to respiratory failure.

Under the Repurposing Drugs in Response to Chemical Threats (ReDIRECT) program from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), BARDA will provide funding to reformulate ENA-001 for intramuscular administration and preclinical pharmacokinetic testing of the new formulation. ENA-001 is the third repurposed candidate being supported by BARDA’s ReDIRECT program.

A new chemical entity (NCE), ENA-001 is an agnostic respiratory stimulant drug that may be useful as a potential emergency treatment for OIRD and other types of respiratory depression. If studies are successful, reformulating ENA-001 for intramuscular administration could enable its rapid use as a medical countermeasure to treat life-threatening respiratory depression in both mass casualty situations and in everyday opioid and other drug overdoses.

An intravenous formulation of ENA-001 is currently in clinical trials and is being evaluated independently as a potential treatment for drug overdose, including OIRD, and for post-operative respiratory depression. Early clinical studies also are independently evaluating ENA-001 as a possible treatment for silent hypoxemia among COVID-19 patients and for use when weaning patients off of mechanical ventilation. Given that ENA-001 acts agnostically via the peripheral chemoreceptors in the carotid body and is not specific to opioids, the drug candidate has the potential to be an effective treatment against combined drug overdoses.

The opioid epidemic affects millions each year and continues to escalate, with a record number of deaths being recorded across the country. Current treatment options for opioid overdoses are limited to a drug class that does not match the extended half-life of highly potent synthetic opioids, such as illicit fentanyls, and that can precipitate withdrawal symptoms. A new treatment that has a different mechanism of action and is agnostic to the cause of respiratory depression is needed to overcome the limitations associated with using existing treatments. ENA-001 has the potential to bolster the United States’ response capabilities for the opioid epidemic by providing additional therapeutics that can save patients’ lives while not inducing potential withdrawal symptoms.

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