News | December 18, 2013

FDA Endorses, Pushes For Abuse-Resistant Opioid Formulations

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 Anna Zanchi, Corporate Communications, at anna.zanchi@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 dependent 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.

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