As opioid lawsuits continue to wind through the courts, some drugmakers are focused on developing treatments for opioid addiction.
Opioid abuse and overdose deaths saw a sharp spike in the late 1990s through today. From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids, according to the U.S. Centers for Disease Control and Prevention (CDC).
Countless lawsuits have been brought against opioid manufacturers by local governments as part of an effort to regain some compensation for the public resources spent battling opioid overdoses and addiction. It’s important to note that many of those issues facing communities across the United States are not fully laid at the feet of prescription opioids. Illegal opioids such as heroin and fentanyl play a significant role. Still, the CDC noted that overdose deaths involving prescription opioids were five times higher in 2017 than in 1999.
In August, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing medication-assisted treatments (MAT) for patients battling opioid addiction. Medication-assisted treatment (MAT) includes popular drugs such as buprenorphine, methadone and naltrexone. The medications are prescribed to curb the euphoric effects of opioids and reduce the body’s cravings.
Companies have certainly been focused on developing treatments to combat addiction and withdrawal symptoms. Last year, the U.S. Food and Drug Administration (FDA) approved a generic version of Suboxone (buprenorphine and naloxone) developed by India-based Dr. Reddy’s and co-developer Mylan NV. Buprenorphine and naloxone are both used to treat adults who are dependent on or addicted to opioids. Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs. Naloxone reverses and blocks the effect of opioids.
Also last year, the FDA approved US WorldMeds, LLC’s Lucemyra (lofexidine hydrochloride), the first non-opioid treatment for management of opioid withdrawal symptoms in adults. Lucemyra was approved for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. The medication is only approved for a 14-day treatment cycle.
When Lucemyra was approved, FDA Commissioner Scott Gottlieb said the regulatory agency has been developing processes to accelerate the development of better treatments for opioid addiction, including those that help manage opioid withdrawal symptoms.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms,” Gottlieb said in a statement.
A recent report noted that the more marketing dollars were spent on doctors led to a higher rate of opioid prescriptions being written. That, of course, helped contribute to the levels of abuse and addiction and, ultimately, overdoses. Opioid dependency has become a focus for some drug manufacturers. There are certainly some treatments currently available, such as Suboxone or methadone, which are used to help addicts break their addiction. Also, Opiant’s Narcan (naloxone) has been instrumental in saving the lives of countless overdose victims across the United States.
As the opioid crisis became national news, prescribing rates of the medication have fallen off. That has happened in part due to some states passing laws regarding limits of opioids that can be prescribed, as well as the rise of other options available for acute pain.
