• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease

March 30, 2018 By Sarah Faulkner

sunovionSunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease.

The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As many as 60% of Parkinson’s patients have these kinds of episodes, according to the company.

“Off episodes, which may be characterized by symptoms such as tremor, stiffness or slow movement, may disrupt the ability to perform everyday activities and may be burdensome for patients, families and caregivers,” Dr. Antony Loebel, EVP & CMO, said in prepared remarks.

Sunovion reported that the therapy performed well compared to a placebo in a pivotal Phase III trial and that the drug’s effect lasted for 90 minutes following initial administration. The film, which has fast-track status with the FDA, was also generally well tolerated by patients in the trial, according to the company.

Sunovion’s drug is gearing up to compete with Acorda Therapeutics‘ (NSDQ:ACOR) inhaled Parkinson’s therapy, Inbrija, which is also under review by the U.S. regulatory agency.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Acorda Therapeutics, Sunovion Pharmaceuticals

IN CASE YOU MISSED IT

  • Another BD Alaris infusion pump recall is Class I
  • Amgen completes $1.9B acquisition of Five Prime Therapeutics
  • Oncopeptides seeks EU marketing authorization for multiple myeloma treatment
  • Horizon touts data from trials for thyroid eye disease infusion treatment
  • Genentech touts study results for spinal muscular atrophy drug in babies

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS