The US opioid market is dominated by non tamper-resistant formulations, but the Food and Drug Administration’s promotion of TRF therapies could well result in the departure of non-TRF treatments from the market, say new forecasts.
Purdue Pharma’s Oxycontin is the only opioid pain treatment among the 50 top-selling pharmaceuticals in the USA, and unless the FDA mandates TRF therapies, further genericisation and lack of novel mechanism of actions (MOAs) will ensure opioids are absent from the top 50 by 2018, warns the study, from Frost & Sullivan.
Nevertheless, it sees large opportunities for tamper-resistant technologies, as well as combination therapies to minimise side effects from opioid products.
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, says the study. Oxycontin leads this category, generating $2.77 billion in sales in 2012, while the transdermal category was led by Johnson & Johnson’s Duragesic (fentanyl transdermal) patch for cancer-induced pain and Endo’s Lidoderm (lidocaine) patch for chronic pain.
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 products have dominated the market, with a 91% market share. This is partly due to the recent requirement for a risk evaluation mitigation strategy (REMS) for extended-release formulations. However, with FDA favouring TRF therapies, extended-release drugs will find greater favour among drug developers, says F&S.
“Another outcome of the FDA’s endorsement of TRFs is the flooding of the pain therapy pipeline with new TRF opioid-based therapies,” says Jennifer Lazar Brice, life sciences global research director at F&S. “In this scenario, Pfizer has significant opportunity to grow, with its broad pipeline of oral (TRFs), transdermals and IV candidates,” she adds.
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 III candidate for this condition, will be of particular interest, the study notes.
It also expects companies which develop a novel, non-opioid MOA therapy to gain particularly in this market. Healthcare providers will be keenly watching developments in calcitonin gene-related (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. This move will create a huge opportunity for new TRF therapies to remain branded,” says Ms Lazar Brice.