Thursday, 25 Apr 2019

You are here

Post-Approval Exploratory Trials with Pregabalin Often Fail

A systematic review of 238 pregabalin (Lyrica) trials for nonapproved indications shows that nearly two-thirds yielded uncertain evidence of efficacy, thereby questioning the off-label use or endorsement in clinical practice guidelines.

Pregabalin was FDA approved in 2004 for neuropathic pain and in 2007 for fibromyalgia.  In October 2017 the FDA approved Lyrica CR (an extended-release pregabalin for neuropathic pain conditions). Pregabalin is expected to go off patent in December 2018 and it's sales are expected to drop from $5 billion in 2018 to roughly $3 billion in 2019.

This review set out to establish the findings of post-approval exploratory and confirmatory postapproval trials (often done in off-label indications) with pregabalin. 

They found 238 trials assessing the efficacy of pregabalin in 33 indications; 5  of whom later received European Medicines Agency and/or US FDA marketing approval.

For new indications 67% (22 of 33), trials failed to generate positive proof of efficacy and generally these were not changed over time or by repeat studies.

These findings question the practice of (often smaller) exploratory and confirmatory trials on new or off-label indications.  Stronger oversight by regulatory agencies and manufacturers should be encouraged to avoid the risk of inappropriate promotion and use of newly approve drugs. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Sleep Myths Debunked

A panel of 10 sleep experts studied 20 common sleep myths and found little or no evidence in support of these beliefs.

Sleep issues are highly prevalent among US adults, but few admit to it or do anything to manage it. 

RheumNowLive On Demand: The History of Fibromyalgia - Dr. Fred Wolfe

A clip from RheumNow Live On Demand. You can access the full library of content from the meeting.

New Sleep Medicine Guidelines for Obstructive Sleep Apnea

The American Academy of Sleep Medicine (AASM) has established new guidelines for the evaluation and treatment of sleep-disordered breathing in adults, specifically guiding the use of positive airway pressure (PAP) in the treatment of obstructive sleep apnea (OSA) in adults. 

Pain Drives the Use of Medical Marijuana

A report from the University of Michigan examined state-wide medical marijuana showing most of it is used for chronic pain.

The authors include Kevin Boehnke, Ph.D., Daniel J. Clauw, M.D., Rebecca L. Haffajee, Ph.D., and Saurav Gangopadhyay, M.P.H. undertook this investigation to to assess why people are using cannabis medically. 

Compounded Pain Creams - Expensive Placebos?

The Annals of Internal Medicine reports that the growth and use of compounded pain creams is unwarranted as they were no better than placebo in a randomized controlled trial, suggesting their higher costs are unjustifiable compared to other topical commercially available agents (lidocaine, diclofenac, capsaicin, etc.). (Citation source: https://buff.ly/2BkTj58)