US FDA Approved OLPRUVA to Treat Urea Cycle Disorder Patients


Acer Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the oral suspension of OLPRUVA (sodium phenylbutyrate) to treat certain UCD patients.

Chris Schelling, CEO and founder of Acer Therapeutics Inc., said that the approval of OLPRUVA by the US FDA of OLPRUVA marks the culmination of our ongoing dedication to develop new and distinct treatment options for those who are affected by rare diseases.

Chris Schelling claims that OLPRUVA provides patients with UCDs with a new, approved treatment option to address some of their potential difficulties with current therapy. The company is very happy to be able to offer this challenging disease to those who live with it.

Chris Schelling went on to say that this approval is the company’s first FDA-approved product and that it demonstrates the company’s ability to quickly identify and develop treatments where science can be applied in novel ways. Additionally, they now have access to the long debt funding option and resources necessary to grow their pipeline of investigational product candidates with this approval.

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Under the previously announced March 2022 loan agreement with affiliates of Marathon Asset Management L.P., OLPRUVA’s approval makes a $42.5 million term loan available to Acer.

The FDA has approved OLPRUVA as an oral suspension for the treatment of UCD patients. UCDs are a group of rare genetic disorders that, if not controlled, can lead to dangerous levels of ammonia in the blood, which can damage the brain and make it harder to think and remember things. Ammonia levels that rise over time are dangerous. As a result, adhering to any protein-restricted diets and taking alternative medications to control ammonia levels are essential.