• 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

FDA asks Titan for more info before clinical trial of ropinirole implant

February 28, 2017 By Sarah Faulkner

FDA asks Titan for more info before clinical trial of ropinirole implantTitan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog.

After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole implant and the applicator used to insert the implant. Titan also needs to identify a principal investigator for the study, although the company said it is in the process of qualifying the participating clinical sites.

Titan said it plans to have final test data of its implant and the applicator within the next few weeks.

“We understand the FDA’s diligence and respect its request for additional information,” executive VP & chief development officer Kate Beebe said in prepared remarks. “We are working quickly to provide the FDA with the additional information required, and are hopeful that we will be able to commence the clinical study toward the end of the 2nd quarter.”

The company’s ropinirole implant is designed to deliver sustained doses of the dopamine agonist for at least 3 months at a time in patients with Parkinson’s disease. Continuous dopaminergic stimulation may alleviate motor complications and delay the onset of the involuntary movements associated with the neuro-degenerative disease, according to Titan.

The company’s long-term, continuous drug delivery platform, ProNeura, was developed to address chronic diseases, including addiction. Probuphine, the company’s 6-month buprenorphine implant for the maintenance treatment of opioid addiction, is the 1st marketed product to provide maintenance treatment continuously for 6 months following a single administration procedure.

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Neurological, Wall Street Beat Tagged With: Titan Pharmaceuticals

IN CASE YOU MISSED IT

  • Senseonics stock is up on Q2 results
  • MedAlliance wins second FDA IDE nod for drug-coated balloon
  • Wells Fargo downgrades Tandem amid rise of automated insulin delivery competition
  • FDA approves first targeted infusion therapy for HER2-low breast cancer
  • Abbott, WeightWatchers partner on diabetes care

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.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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