Pharmaceutical company focusing on acquisition, development, and commercialization of therapies for rare diseases, Acer Therapeutics, and Relief Therapeutics Holding AG (OTCMKTS:RLFTF) on August 9, 2021, announced the submission of a New Drug Application to the US FDA for ACER-001 (sodium phenylbutyrate) to treat Urea Cycle Disorders.
A nitrogen-binding agent, ACER-001 is being utilized for use as adjunctive therapy in the chronic management of patients with UCDs.
The company is expecting to receive notification from the drug administration within 60 days of the filing of submission.
505(b)(2) NDA submission, supported by results from two erstwhile announced bioequivalence trials, the company has got Agreement Letter from FDA to its initial Pediatric Study Plan highlighting the agreed-upon approach addressing the needs of pediatric patients with UCDs.
Chris Schelling, Chief Executive Officer and Founder of Acer said that the submission of NDA for ACER-001 is a milestone for bringing potential alternative treatment options to patients with UCDs. Schelling said that the firm aims to work with the FDA review process and advance preparation for the launch of ACER-001 besides regulatory submissions in Europe.
Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics said that the company will continue efforts for its development in Europe through the submission of a Marketing Authorization Application in Europe by the end of 2021.
There is no surety yet on the acceptance of the product yet.