Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Alkermes Submits sNDA for VIVITROL

By Drug Discovery Trends Editor | April 13, 2010

Alkermes, Inc. announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline. The sNDA is based on the positive results from a recent phase 3 study assessing the efficacy and safety of VIVITROL for opioid dependence. VIVITROL is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence. If approved by the FDA for the treatment of opioid dependence, VIVITROL would be the first and only non-narcotic, non-addictive drug agent available in a once-monthly formulation.

“Opioid dependence is a serious disease affecting millions of people yet there are limitations with currently available therapies,” stated Richard Pops, Chief Executive Officer of Alkermes. “As the first and only non-narcotic, non-addictive, once-monthly treatment option, VIVITROL for opioid dependence could significantly change the treatment paradigm. By seeking priority review, we hope to bring this much needed treatment to patients as soon as possible.”

The submission of the sNDA follows a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints. Data from the intent-to-treat (ITT) analysis showed that patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens, compared to patients treated with placebo (p<0.0002). Furthermore, the median patient taking VIVITROL had 90% opioid-free urine screens during the evaluation phase of the study and patients treated with VIVITROL demonstrated a significant reduction in opioid craving compared to patients treated with placebo as measured by a visual analog scale. VIVITROL was generally well tolerated in the study and no patients on VIVITROL discontinued the study due to adverse events. The most common adverse events experienced by patients receiving VIVITROL during the study were nasopharyngitis and insomnia.

Date: April 13, 2010
Source: Alkermes, Inc. 


Filed Under: Drug Discovery

 

Related Articles Read More >

Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority
Portrait photo of Pfizer EVP and Medtronic board member Lidia Fonseca
Medtronic appoints Pfizer EVP as independent board director

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 Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. 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
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50