Olpruva FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 31, 2022.
FDA Approved: Yes (First approved December 22, 2022)
Brand name: Olpruva
Generic name: sodium phenylbutyrate
Dosage form: for Oral Suspension
Previous Name: ACER-001
Company: Acer Therapeutics Inc.
Treatment for: Urea Cycle Disorders
Olpruva (sodium phenylbutyrate) is a nitrogen-binding agent for the treatment of patients with urea cycle disorders (UCDs).
- Olpruva is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
Limitations of Use: Olpruva is not indicated for the treatment of acute hyperammonemia. - Olpruva received FDA approval under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FDCA). Data provided from clinical studies demonstrated that Olpruva was bioequivalent to the reference listed drug (RLD), Buphenyl® powder.
- Olpruva is supplied as pellets in packets for reconstitution, which are combined with Mix-Aid suspension and water to form an oral suspension. The dosage for Olpruva oral suspension is calculated according to body surface area, and administered in three to six divided doses daily. Each dose should be taken with food.
- Warnings and precautions associated with Olpruva include neurotoxicity, hypokalemia, and new-onset or worsening edema.
- Common adverse reactions include menstrual dysfunction, decreased appetite, body odor, and bad taste or taste aversion.
Development timeline for Olpruva
Further information
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