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The Food and Drug Administration (FDA) has approved ONAPGO\u2122 (apomorphine hydrochloride) as a subcutaneous apomorphine infusion device for the treatment of \u201coff\u201d episodes in Parkinson\u2019s disease (PD), providing patients with a new, on-demand therapy to rapidly alleviate motor symptoms when standard medications wear off.<\/p>\n
PD is the most common neurodegenerative movement disorder,1<\/sup> with its global prevalence increasing significantly over the last two to three decades.2<\/sup> Patients treated with mainstay regimens experience periods of GOOD ON time, when medication is effective, and OFF time, when oral levodopa no longer provides symptom relief, leading to the return of motor impairments.3<\/sup><\/p>\n ONAPGO\u2122 is the first and only wearable subcutaneous apomorphine infusion device that provides continuous treatment during the waking day, offering patients more consistent control of motor fluctuations.<\/p>\n The FDA\u2019s approval is based on results from a Phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study (N=107) evaluating the efficacy and safety of ONAPGO\u2122. The primary efficacy endpoint was the mean change in total daily OFF time from baseline to the end of the 12-week treatment period, as recorded in patient diaries. Key secondary endpoints included the mean change in daily GOOD ON time (ON time without troublesome dyskinesia) and Patient Global Impression of Change (PGIC) scores.<\/p>\n Supernus plans to launch ONAPGO\u2122 to patients in the USA in the second quarter of 2025.<\/p>\n References<\/strong>:<\/p>\n Disclosures<\/i><\/b>: This article was created by the touchNEUROLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model].\u00a0<\/i>https:\/\/chat.openai.com\/chat<\/i><\/a>.) The content was developed and edited by human editors. No funding was received in the publication of this article.<\/i><\/p>\n Join our global community today for access to thousands of peer-reviewed articles, expert insights, and learn-on-the-go education across 150+ specialties, plus concise email updates and newsletters so you never miss out.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" The Food and Drug Administration (FDA) has approved ONAPGO\u2122 (apomorphine hydrochloride) sublingual film for the treatment of \u201coff\u201d episodes in Parkinson\u2019s disease (PD), providing patients with a new, on-demand therapy to rapidly alleviate motor symptoms when standard medications wear off.<\/p>\n","protected":false},"featured_media":95707,"template":"","class_list":["post-95702","insight","type-insight","status-publish","has-post-thumbnail","hentry","vocabulary_1-parkinsons-disease"],"acf":[],"_links":{"self":[{"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/insight\/95702","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/insight"}],"about":[{"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/types\/insight"}],"version-history":[{"count":6,"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/insight\/95702\/revisions"}],"predecessor-version":[{"id":95752,"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/insight\/95702\/revisions\/95752"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/media\/95707"}],"wp:attachment":[{"href":"https:\/\/touchneurology.com\/wp-json\/wp\/v2\/media?parent=95702"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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