FDA Endorses, Pushes for Abuse-resistant Opioid Formulations: Transition to Disrupt Pain Market

Published by

FDA Endorses, Pushes for Abuse-FDA Endorses, Pushes for Abuse- resistant Opioid Formulations: Transition to Disrupt Pain Market PR Newswire MOUNTAIN VIEW, California, Dec. 17, 2013 -- Frost & Sullivan: The removal of non-TRF opioids, creates significant opportunity for innovative therapies The opioid market is dominated by non-tamper resistant formulations (TRFs), but the Food and Drug Administration's (FDA's) promotion of TRF therapies could well result in the departure of non-TRF therapies from the market and shake up its structure. Purdue Pharma's Oxycontin is the only opioid pain treatment among the top 50 selling pharmaceutical products in the U.S. Unless the FDA mandates TRF therapies, further genericization and lack of novel mechanism of actions (MOAs) will ensure opioids are unrepresented in the top 50 by 2018. Despite these debilitating trends, large opportunity remains for tamper resistant technologies, as well as combination therapies to minimize side effects from opioid products. New analysis from Frost & Sullivan's Competitive Analysis of the Global Opioid Therapeutics Market (http://www.lifesciences.frost.com), finds, with 25 million Americans suffering from moderate-to-severe chronic pain that interferes with their daily lives, orally-delivered pain products will continue to dominate the market. Purdue's Oxycontin leads this category, generating $2.77 billion in sales in 2012.
Published : Tuesday, December 17, 2013
Reading/s : 14
Origin : prnewswire.com
Number of pages: 7
See more See less
FDA Endorses, Pushes for Abuse-resistant Opioid Formulations: Transition to Disrupt Pain Market

PR Newswire

-- Frost & Sullivan: The removal of non-TRF opioids, creates significant opportunity for innovative therapies

The opioid market is dominated by non-tamper resistant formulations (TRFs), but the Food and Drug Administration's (FDA's) promotion of TRF therapies could well result in the departure of non-TRF therapies from the market and shake up its structure.

Purdue Pharma's Oxycontin is the only opioid pain treatment among the top 50 selling pharmaceutical products in the U.S. Unless the FDA mandates TRF therapies, further genericization and lack of novel mechanism of actions (MOAs) will ensure opioids are unrepresented in the top 50 by 2018. Despite these debilitating trends, large opportunity remains for tamper resistant technologies, as well as combination therapies to minimize side effects from opioid products.

New analysis from Frost & Sullivan's Competitive Analysis of the Global Opioid Therapeutics Market (http://www.lifesciences.frost.com), finds, with 25 million Americans suffering from moderate-to-severe chronic pain that interferes with their daily lives, orally-delivered pain products will continue to dominate the market. Purdue's Oxycontin leads this category, generating $2.77 billion in sales in 2012. The transdermal category was led by Johnson & Johnson's Duragesic patch for cancer-induced pain and Endo's Lidoderm patch for chronic pain.

For more information on this research, please email Jennifer Carson, Corporate Communications, at jennifer.carson@frost.com.

The FDA's push for abuse-deterrent formulations will also spell a boom for extended-release opioids. So far, in spite of the continued development of extended-release formulations, immediate-release formulations have dominated the market with 91 percent of the market share. This is partly due to the recent requirement for a risk evaluation mitigation strategy (REMS) for extended-release formulations. However, with the FDA favoring TRF therapies, extended-release drugs will find greater favor among drug developers.

"Another outcome of the FDA's endorsement of TRFs is the flooding of the pain therapy pipeline with new TRF opioid-based therapies," said Frost & Sullivan Life Sciences Global Research Director Jennifer Lazar Brice. "In this scenario, Pfizer has significant opportunity to grow, with its broad pipeline of oral (TRFs), transdermals and IV candidates."

As opioids are the mainstay of pain treatment, there is a substantial market for a therapy for opioid-induced constipation. Nektar Therapeutics' NKTR-118, a Phase 3 candidate to treat the issue, will be of particular interest.

Companies that can develop a novel, non-opioid MOA therapy will particularly stand to gain in this market. Healthcare providers will be keenly watching the developments in calcitonin gene related peptide (CGRP)-targeted therapies.

"Overall, the future of the pain market is heavily dependant upon the FDA's decision to remove non-TRF generic therapies from the market," noted Brice. "This move will create a huge opportunity for new TRF therapies to remain branded."

Competitive Analysis of the Global Opioid Therapeutics Market is part of Frost & Sullivan's newly repositioned Life Sciences Growth Partnership Service program, which now includes the Competitive Intelligence research service. All therapeutic research services included in this subscription provide analyses and dashboards for competitive factors, clinical trials, timelines, M&As, products and vendors; as well as companies to watch, position-altering strategies, and market opportunities and predictions. The research also includes company and key opinion leader interviews, recruitment statuses, safety/efficacy analyses, market milestones, and best practices in the industry. This Competitive Intelligence enables companies to better position their sales and marketing strategy towards clinical development programs and prioritizations.

Connect with Frost & Sullivan on social media, including Twitter, Facebook, SlideShare and LinkedIn, for the latest news and updates.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today's market participants.

Our "Growth Partnership" supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructure is entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Contact Us: Start the discussion

Join Us: Join our community

Subscribe: Newsletter on "the next big thing"

Register: Gain access to visionary innovation

Competitive Analysis of the Global Opioid Therapeutics Market
ND3C-52

Contact:
Jennifer Carson
Corporate Communications – North America
P: +1-210-247-2450
E: jennifer.carson@frost.com

LinkedIn: Transform Health Group
Twitter: @Frost_Sullivan
Facebook: Frost & Sullivan

http://www.frost.com

Be the first to leave a comment!!

12/1000 maximum characters.