Acorda Therapeutics Announces Biopas Laboratories' Submission to Regulatory Authorities in Six Latin American Nations for INBRIJA® Approval

7 November 2023

Acorda Therapeutics, Inc. (Nasdaq: ACOR) has made an announcement regarding new regulatory submissions for the approval of INBRIJA® (levodopa inhalation powder) in six Latin American countries through its partner, Biopas Laboratories (Biopas). INBRIJA is currently indicated in the United States for the intermittent treatment of OFF episodes in adult patients with Parkinson's disease (PD) who are undergoing carbidopa/levodopa treatment.

Biopas has formally applied for marketing approval of INBRIJA in Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru. Additionally, it plans to file further regulatory submissions for INBRIJA's approval in Chile in late 2023 and in Mexico and Brazil in 2024.

Acorda, expressed his enthusiasm about this progress, stating, "We are pleased with Biopas' submissions for INBRIJA's approval in six Latin American countries, with expectations of up to five approvals in 2024. This represents a significant advancement for individuals living with Parkinson's disease in these regions. Biopas has a strong track record in the commercialization of CNS therapies in Latin America, and we extend our gratitude to them for their commitment to providing greater access to our vital medication."

INBRIJA is a prescribed inhaled levodopa medication intended to address the reappearance of Parkinson's symptoms, known as OFF episodes, in individuals with Parkinson's disease who are receiving carbidopa/levodopa treatment. INBRIJA does not replace standard carbidopa/levodopa medications and should not be used by individuals with Parkinson's disease who have taken or are currently taking nonselective monoamine oxidase inhibitors such as phenelzine or tranylcypromine within the past two weeks. The most frequently observed side effects of INBRIJA include cough, upper respiratory tract infections, nausea, and alterations in the color of saliva or spit.

 

Source: businesswire.com