The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, the FDA said it could not approve the application for the apomorphine sublingual film in its present form.
The U.S. Food and Drug Administration (FDA) rejected Sunovion Pharmaceuticals’ experimental treatment for OFF episodes of Parkinson’s disease.
The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, which was submitted in March 2018, the FDA said it could not approve the application for the apomorphine sublingual film in its present form. The FDA requested additional information and analyses, but no new clinical studies are required, Sunovion said in its brief announcement.
Antony Loebel, Sunovion’s chief medical officer and head of global clinical development for Sumitomo Dainippon Pharma Group, Sunovion’s parent company, said Sunovion is committed to working with the FDA to address its requests, in order to “bring apomorphine sublingual film to patients as expeditiously as possible.”
Sunovion’s apomorphine sublingual film was being developed for the treatment of OFF episodes of Parkinson’s disease. People diagnosed with Parkinson’s often deal with times classified as “ON” and “OFF.” OFF periods are characterized by the reemergence of Parkinson’s symptoms. In OFF times, patients experience periods of decreased mobility.
APL-130277, a novel formulation of apomorphine and a dopamine agonist, is being developed for the on-demand management of OFF episodes associated with Parkinson’s disease. Apomorphine is currently FDA approved for the acute, intermittent treatment of hypomobility, “OFF” episodes associated with advanced PD. It is currently available in the U.S. as a subcutaneous injection. APL-130277 is intended to “rapidly convert” Parkinson’s disease patients from the OFF to the ON state, Sunovion said.
Prior to submitting the NDA to the FDA, Sunovion’s apomorphine film (CTH-300) was evaluated in a 12-week, placebo-controlled Phase III trial. After 12 weeks of dosing, the treatment hit its primary endpoint of a mean change in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III Motor Examination at 30 minutes. The key secondary endpoint the trial hit was the percentage of patients with a patient-rated full ON response within 30 minutes at the 12-week point.
“OFF episodes are a common and challenging part of Parkinson’s disease with few existing treatment options,” Loebel said in a statement.
Sunovion licensed apomorphine sublingual film from Warren, N.J.-based Aquestive Therapeutics. This morning, Aquestive said interest in apomorphine film is high, despite the FDA’s CRL. Although no longer part of its pipeline, Aquestive said that additional treatment options for Parkinson’s disease patients experiencing OFF episodes are important to that community. The company said that apomorphine sublingual film “remains indicative of the future value” in its intellectual property license with Sunovion.
