{"id":27381,"date":"2026-06-29T12:00:00","date_gmt":"2026-06-29T10:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=9deb3dc1c4e3c1fc6a7bbffe3895a89b"},"modified":"2026-06-29T12:00:00","modified_gmt":"2026-06-29T10:00:00","slug":"zambon-announces-positive-chmp-opinion-for-hopledo-ipx203-for-adults-with-parkinsons-disease-and-moderate-to-severe-motor-fluctuations","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=27381","title":{"rendered":"Zambon Announces Positive CHMP Opinion for Hopledo\u00ae (IPX203) for Adults with Parkinson\u2019s Disease and Moderate to Severe Motor Fluctuations"},"content":{"rendered":"<ul class=\"bwlistdisc\">\n<li>\nPositive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more \u201cGood ON\u201d time with fewer daily doses compared with immediate-release levodopa\/carbidopa<\/li>\n<li>\nMore than one million people are living with Parkinson\u2019s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options<\/li>\n<li>\nHopledo\u00ae contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time<\/li>\n<li>\nIf approved, Zambon expects to make Hopledo\u00ae progressively available to patients with Parkinson\u2019s disease across Europe starting October 2026<\/li>\n<\/ul><p>MILAN--(BUSINESS WIRE)--<a href=\"https:\/\/twitter.com\/hashtag\/Parkinson?src=hash\" >#Parkinson<\/a>--Zambon today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European Medicines Agency (EMA) for Hopledo\u00ae (modified-release levodopa\/carbidopa) for the treatment of adult patients with Parkinson\u2019s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa\/DDC inhibitor-based treatment regimens.<\/p><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260623275761\/en\/2837348\/5\/Zambon_LogoPositivoRGB.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260623275761\/en\/2837348\/22\/Zambon_LogoPositivoRGB.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260623275761\/en\/2837348\/5\/Zambon_LogoPositivoRGB.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260623275761\/en\/2837348\/21\/Zambon_LogoPositivoRGB.jpg\" \/><\/a><p>\nCHMP recommendation is based on data from the Phase 3 RISE-PD trial, which compared Hopledo\u00ae with immediate release levodopa\/carbidopa (LD\/CD) formulation in patients with Parkinson\u2019s disease and moderate to severe motor fluctuations. In the study, Hopledo\u00ae demonstrated a significant increase in Good ON time over immediate release LD\/CD with fewer daily doses and a comparable safety profile<sup>1<\/sup>.<\/p><p>\nHopledo\u00ae is a first-in-class, oral, modified-release formulation of LD\/CD designed for the treatment of fluctuations of Parkinson\u2019s disease, the fastest growing neurological condition in the world according to the World Health Organization<sup>2<\/sup>. Despite available oral treatments, there is a substantial need for new therapeutic options; during the course of the disease, more than 80% of patients with Parkinson\u2019s disease experience motor fluctuations<sup>3<\/sup>. Hopledo\u00ae contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of benefit, sustaining the levodopa therapeutic effect for a longer period of time. In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo\u00ae in the European Union, United Kingdom and Switzerland. Hopledo\u00ae, formerly known as IPX203, is already approved and marketed in the United States under the brand name CREXONT\u00ae, providing established regulatory and commercial experience as the therapy advances toward European approval.<\/p><p>\n\u201cIn Parkinson\u2019s disease treatment is focused on maintaining consistent symptom control by prolonging levodopa benefit, reducing \u201cOff\u201d time, and simplifying dosing. Hopledo ability to extend \u201cGood On\u201d time with fewer daily doses offers a significant advancement in the management of motor symptoms and in achieving more stable and sustained therapeutic effects,\u201d said <b>Prof.<\/b> <b>Fabrizio Stocchi, Full Professor of Neurology at San Raffaele University in Rome and Head of Clinical Research in Movement Disorders and of the Parkinson\u2019s Disease Research Centre.<\/b><\/p><p>\n\u201cThe CHMP positive opinion represents an important step towards expending access to this important therapy to patients in Europe. As the disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo addresses this unmet need by providing longer-lasting \u201cGood On\u201d time with fewer daily doses. This achievement underscores Zambon\u2019s leadership in Parkinson\u2019s disease and our unwavering commitment to more than one million people currently living with Parkinson\u2019s disease in the EU,\u201d said <b>Mathias Knecht, M.D., Chief Medical Officer Innovative Therapies, Zambon.<\/b><\/p><p>\nSubject to European Commission approval, Zambon expects to begin the phased introduction of Hopledo\u00ae across European markets beginning in October 2026. The company is working closely with the healthcare authorities and other stakeholders to support timely patient access to this important new treatment option for patients across Europe who continue to experience motor fluctuations despite current oral therapies.<\/p><p>\n<b>About the RISE-PD Phase 3 Trial\n<br\/><\/b>The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX203 compared with IR LD\/CD in the treatment of patients with PD with motor fluctuations. The primary endpoint of the trial assessed the change from baseline in \u201cGood On\u201d time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoints assessed the change from baseline in \u201cOff\u201d time in hours per day, proportion of patients who were either \u201cmuch improved\u201d or \u201cvery much improved\u201d in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older.<\/p><p>\n<b>About Zambon\n<br\/><\/b>For further information on Zambon please visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.zambon.com&amp;esheet=54558695&amp;newsitemid=20260623275761&amp;lan=en-US&amp;anchor=www.zambon.com&amp;index=1&amp;md5=9ce92de2a5528a3cfe3207338e32dd3b\" rel=\"nofollow\" shape=\"rect\">www.zambon.com<\/a><\/p><p>\n<b>References\n<br\/><\/b>1. Hauser RA, et al. <i>JAMA Neurol<\/i>. 2023;80(10):1062-1069 and Supplementary materials\n<br\/>2. <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.who.int%2Fpublications%2Fi%2Fitem%2F9789240050983&amp;esheet=54558695&amp;newsitemid=20260623275761&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.who.int%2Fpublications%2Fi%2Fitem%2F9789240050983&amp;index=2&amp;md5=72480f3dcb2fed327339888f5d54048b\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.who.int\/publications\/i\/item\/9789240050983<\/a><br\/>3. Fabbri M, et al. Off-time Treatment Options for Parkinson\u2019s Disease. Neurol Ther. 2023;12(2):391-424;\n<br\/>Demailly A, et al. Effectiveness of Continuous Dopaminergic Therapies in Parkinson\u2019s Disease: A Review of L-DOPA Pharmacokinetics\/ Pharmacodynamics. J Parkinsons Dis. 2024;14(5):925-939.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\n<b>Zambon<\/b><br\/><a  href=\"mailto:media@zambongroup.com\" rel=\"nofollow\" shape=\"rect\">media@zambongroup.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more \u201cGood ON\u201d time with fewer daily doses compared with immediate-release levodopa\/carbidopa<\/p>\n<p>More than one million people are living with Parkin&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-27381","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/27381","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27381"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/27381\/revisions"}],"predecessor-version":[{"id":27382,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/27381\/revisions\/27382"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27381"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27381"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27381"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}