Alberto Espay, MD, MSc

“It was accomplished, from the standpoint of the study design, to reduce the number of doses, and I think that’s in and of itself important, but if you factor in clinical practice, it’ll be important to reduce the OFF times, or, ideally, eliminate it. You can conceive that with IPX-203.”

Amneal Pharmaceuticals is evaluating an investigational therapy for the treatment of Parkinson disease, known as IPX-203. In August, positive topline results the phase 3 clinical trial, RISE-PD (NCT03670953), showed that it may have potential for individuals with Parkinson disease (PD) who experience motor fluctuations. The trial was conducted at 108 clinical sites in the US and Europe and randomized 506 patients with PD aged 40 years and older. Currently, a 9-month safety extension study is ongoing.

In the study, the IPX-203 group demonstrated greater good ON time from baseline after the 13-week double-blind treatment period compared with a group of patients on immediate-release carbidopa/levodopa (CD/LD). Ultimately, treatment with the investigational oral CD/LD extended-release capsules resulted in 0.53 more hours of good ON time than immediate-release CD/LD (

= .0194), when compared with baseline. Based on the results and other supportive data it holds, Amneal noted that it plans to submit a new drug application for IPX-203 with the FDA in mid-2022.

 spoke with investigator Alberto J. Espay, MD, MSc, professor of neurology, director, James J. and Joan A. Gardner Family Center, and research chair, Parkinson’s Disease and Movement Disorders, University of Cincinnati Health, to learn more about the data from the trial. He offered his thoughts on the efficacy of the therapy and his perspective on the data.

REFERENCE
Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations. News relase. Amneal Pharmaceuticals. August 25, 2021. Accessed October 12, 2021. https://www.businesswire.com/news/home/20210825005679/en/Amneal-Announces-Positive-Topline-Results-from-Pivotal-Phase-3-RISE-PD-Clinical-Trial-of-IPX-203-in-Patients-with-Parkinson%E2%80%99s-Disease-Who-Experience-Motor-Fluctuations

Videos

In light of the RISE-PD study data, the research chair for Parkinson’s Disease and Movement Disorders at University of Cincinnati Health offered insight into IPX-203 in Parkinson disease. [WATCH TIME: 3 minutes]

 IPX-203 as a Parkinson Disease Treatment: Alberto J. Espay, MD, MSc

“As it happens with many of these trials, most of the patients who came on to this trial had a good 6 hours or so of baseline OFF time. What was interesting is the study was really positive in terms of both a demonstration of a good ON time compared to immediate-release carbidopa/levodopa as well as a corresponding reduction in the OFF time.”

In August, Amneal Pharmaceuticals announced positive topline results from its pivotal phase 3 clinical trial, RISE-PD (NCT03670953) that evaluated the company’s investigational formulation, IPX-203, in individuals with Parkinson disease (PD) who experience motor fluctuations.

The trial was conducted at 108 clinical sites in the US and Europe and randomized 506 patients with PD aged 40 years and older. Currently, a 9-month safety extension study is ongoing. RISE-PD met its primary end point, demonstrating more good ON time from baseline after the 13-week double-blind treatment period. Amneal also announced that based on the results and other supportive data it holds, it plans to submit a new drug application for IPX-203 with the FDA in mid-2022.

Alberto J. Espay, MD, MSc, professor of neurology, director, James J. and Joan A. Gardner Family Center, and research chair, Parkinson’s Disease and Movement Disorders, University of Cincinnati Health, offered an overview of the trial in a conversation with 

. Espay, an investigator in the trial, shared his insight on the findings and IPX-203’s potential to offer benefit to patients.

REFERENCE
Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations. News release. Amneal Pharmaceuticals. August 25, 2021. Accessed October 12, 2021. https://www.businesswire.com/news/home/20210825005679/en/Amneal-Announces-Positive-Topline-Results-from-Pivotal-Phase-3-RISE-PD-Clinical-Trial-of-IPX-203-in-Patients-with-Parkinson%E2%80%99s-Disease-Who-Experience-Motor-Fluctuations

The research chair for Parkinson’s Disease and Movement Disorders at University of Cincinnati Health discussed the therapy’s results in a study of its effect on Parkinson disease. [WATCH TIME: 6 minutes]

The RISE-PD Study of IPX-203: Alberto J. Espay, MD, MSc

“The symptomatic therapies are those that are meant to harness the power of, usually, magnifying deficiencies in certain neurotransmitters. Dopamine deficiency is one where there is much to be developed and improved on, and, in fact, novel levodopa formulations are among the best types of interventions to bring forth in terms of symptomatic therapies.”

Physicians who specialize in the treatment of movement disorders, particularly Parkinson disease (PD), levodopa has maintained its place as a major player in care, operating as a gold standard for therapeutic intervention. Although, the therapy has its limitations, including in administration and efficacy with long-term use.

Still, Levodopa offers an option for patients to control their motor symptoms. Despite the existence of this gold-standard treatment, patients with PD still face a number of nonmotor challenges, though, including cognitive issues, psychosis, and autonomic issues, among others. Alberto J. Espay, MD, MSc, professor of neurology, director, James J. and Joan A. Gardner Family Center, and research chair, Parkinson’s Disease and Movement Disorders, University of Cincinnati Health, explained the current state of care for these issues in a conversation with 

The research chair for Parkinson’s Disease and Movement Disorders at University of Cincinnati Health spoke to the current state of treatment for Parkinson disease. [WATCH TIME: 2 minutes]

The Parkinson Disease Treatment Landscape: Alberto J. Espay, MD, MSc

“There are probably very different disease subtypes contained within the umbrella of Parkinson disease.”

At the American Academy of Neurology's (AAN) 70th Annual Meeting in Los Angeles, California, 

 sat with Albert Espay, MD, MSc, to talk about the transformation of the field of thought surrounding Parkinson disease (PD) treatment. 

Espay, a professor of neurology, Director of the James J. and Joan A. Gardner Family Center Research Chair for Parkinson and Movement Disorders at UC Health, noted that although the management of symptoms related to dopamine deficiency has been quite successful, the development of disease-modifying therapies has been underwhelming.

He explained that part of this struggle met by the Parkinson treatment community has been due to the current, and longstanding, conceptualization of PD altogether. Espay argues that while the current belief in the clinical criteria has allowed for success in symptomatic strategies, it has, ultimately, held the field back from achieving progress in the targeting of punitive, disease-modifying interventions. 

The UC Health professor of neurology argued that with the current view on Parkinson disease, the field is missing the mark for disease-modifying interventions.

Alberto Espay, MD, MSc

Articles

IPX-203 as a Parkinson Disease Treatment: Alberto J. Espay, MD, MSc

The RISE-PD Study of IPX-203: Alberto J. Espay, MD, MSc

The Parkinson Disease Treatment Landscape: Alberto J. Espay, MD, MSc

Alberto Espay, MD, MSc: Modifying Thought About Parkinson Disease