Levodopa hydrate

Celon Pharma said its therapy has a “unique pharmacodynamic profile, characterized by rapid enzyme dissociation, which distinguishes it from other PDE10A inhibitors.”\n Celon Pharma’s PDE10A inhibitor has reduced involuntary movements in a phase 2 trial of individuals with Parkinson’s disease.The Polish biotech tested two daily doses of the drug, dubbed CPL’36, in the study of 105 adults with Parkinson’s disease who had levodopa-induced dyskinesia (LID)—a term for involuntary movements caused by long-term use of the widely used Parkinson’s drug levodopa.By Week 4, the improvement in the Unified Dyskinesia Rating Scale was 12.3 units for patients who received the 20-mg dose and 13.58 units for those who received a 30-mg dose, hitting the trial’s primary endpoint.The study also hit “most” of its secondary endpoints, including a statistically significant difference in a related dyskinesia rating scale, the company added, without going into more details.No patients in the 20-mg cohort experienced severe adverse events, compared to 5.7% of the 40-mg group and 8.8% of patients who received placebo. A total of 11.1% of patients in the 20-mg dosing arm discontinued their medication due to treatment-related emergent adverse events, compared to 8.6% of the 40-mg cohort and 2.9% of the placebo group.“I am very pleased that the clinical effect of CPL\'36 has now been confirmed also for the treatment of LID dyskinesia in Parkinson\'s disease,” Celon’s CEO Maciej Wieczorek, Ph.D., said in a statement.  “We believe that CPL’36 has potential to significantly contribute to the expansion and advancement of the global market for Parkinson\'s disease pharmacotherapy, and to provide sizeable clinical benefits to LID patients who are underserved by current treatments,” Wieczorek added.The post-market readout yesterday follows a “statistically significant” benefit demonstrated in a separate phase 2 trial in individuals with schizophrenia last year.Celon isn’t the only biotech trying to inhibit PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition. Swiss biotech Noema Pharma\'s gemlapodect—originally developed by Roche—reduced tic severity in a small phase 2 trial of 15 patients with Tourette syndrome last year. Meanwhile, EuMentis Therapeutics is aiming to take a PDE10A inhibitor into phase 2 in the first quarter of 2025, but it has failed to hit targets for the program in the past.Joanna Sierzputowska-Prarat, Celon’s main clinical neuropsychiatry lead, said in today’s release that CPL’36 has a “unique pharmacodynamic profile, characterized by rapid enzyme dissociation, which distinguishes it from other PDE10A inhibitors.”“We believe this attribute is key to the positive clinical outcomes we have generated thus far,\" Sierzputowska-Prarat added.

Onapgo is approved for adult Parkinson’s patients experiencing motor fluctuations. Credit: Inside Creative House via Getty Images. Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson’s disease. Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval. The company acquired Onapgo, previously known as SPN-830, from US WorldMeds in 2020. Soon after, Supernus submitted its first application for FDA review. However, in 2020, the agency issued a refusal-to-file (RTF) letter, determining that the submission was incomplete and not ready for formal review. Supernus resubmitted the application twice, receiving complete response letters (CRLs) both times. The first 2022 rejection required further analysis of the infusion device and drug product, while the most recent CRL, issued in April 2023, cited product quality concerns and deficiencies in the master file for the proprietary pump. The company resubmitted its fourth application in August, leading to the current approval. Onapgo will now be available for adult Parkinson’s disease patients experiencing motor fluctuations. The wearable pump is designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is intended for patients experiencing “off” periods, where medication wears off and symptoms return or worsen. The approval is based on a Phase III, 12-week study (NCT02006121) involving 107 patients. Onapgo led to a drop in daily “off” time and an increase in daily good “on” time, defined as periods without dyskinesia and the patient’s global impression of change (PGIC). Supernus plans to launch Onapgo in the second quarter of 2025, supported by a team of specialists, a nurse education programme, and access support services. The approval adds Onapgo to a growing list of infusion-based Parkinson’s treatments. AbbVie ’s Vyalev (foscarbidopa and foslevodopa), a continuous subcutaneous infusion therapy combining prodrugs of carbidopa and levodopa, was approved in October 2024 after three regulatory attempts. The FDA’s initial rejection of Vyalev did not involve efficacy or safety concerns but requested additional information on the pump device. The second rejection followed findings of issues at a third-party manufacturer. AbbVie set a precedent in 2015 with its Parkinson’s disease infusion pump therapy Produodopa (foslevodopa foscarbidopa), sparking innovation in drug delivery systems as companies looked for alternatives for conventional oral treatments.