Acer Therapeutics and Relief Therapeutics Receive the US FDA’s Approval of Olpruva for Urea Cycle Disorders
Shots:
- The US FDA has approved Olpruva (sodium phenylbutyrate) as an oral suspension for UCDs. The therapy was developed by Acer & its collaboration partner Relief Therapeutics
- The approval was based on the 2 bioequivalence trials results evaluating Olpruva vs Buphenyl powder which showed similar relative bioavailability for phenylbutyrate & phenylacetate vs Buphenyl (sodium phenylbutyrate). The results were presented at SIMD 2022 & the GMDI Conference 2022
- Olpruva is supplied in dosage strengths of 2/3/4/5/6/6.67g of sodium phenylbutyrate. Acer intends to offer patient support services to facilitate access to therapy while navigator is designed to assist UCD patients with support, access, education, and adherence
Ref: GlobalNewire | Image: Acer Therapeutics
Related News:- Acer Therapeutics and Relief Receive the US FDA’s CRL for ACER-001’s NDA to Treat Urea Cycle Disorders
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