In a landmark approval on June 25th, the Food and Drug Administration (FDA) approved Epidiolex® (oral cannabidiol solution) for the treatment of seizures associated with Lennox-Gestaut Syndrome or Dravet Syndrome, in children two years of age and older. Epidiolex is the first marijuana-based drug approved for use in the United States. Two other drugs previously […] Continue
This week, the California Workers’ Compensation Institute (CWCI) released a study documenting opioid use in Workers’ Compensation Medical Set-Asides (WCMSAs). The study (for which MEDVAL contributed both data and advice concerning MSAs) focused on a specific dataset of CMS approved California WCMSAs from 2015 and 2016, against a control group of claims from 2006 through […] Continue
Nationwide, states and workers’ compensation boards have been taking measures to curb the overprescribing and misuse of opioids and the crisis that has ensued as a result. Nonetheless, opioid addiction continues to be a growing concern. In an effort to help states combat the opioid epidemic, the U.S. Department of Health and Human Services (HHS) […] Continue
On March 14, 2017, a Food and Drug Administration (FDA) advisory committee found that the risks associated with use of Opana ER (oxymorphone hydrochloride) outweighed the potential benefits. Opana ER is an opioid pain medication, which was first introduced in 2006 and then reintroduced in a new abuse deterrent formulation in 2012. The new formulation was designed […] Continue
Last week, the FDA approved Arymo ER, an abuse-deterrent formulation of morphine sulfate extended release tablets, marketed by Egalet Corporation. Arymo ER comes in three dosage strengths: 15mg, 30mg, and 60mg and slated to hit the market first quarter 2017. Arymo ER is the latest addition to the growing list of abuse-deterrent opiates like Troxyca […] Continue
Ketamine is a dissociative anesthetic approved by the FDA in 1970 to induce and maintain general anesthesia. It is considered a dissociative drug because it distorts perceptions as well as produces feelings of detachment. Ketamine is a potent open channel N-methyl-D-aspartate (NMDA)-receptor antagonist. NMDA receptor excitation results in an influx of calcium into the cell […] Continue
On May 26, 2016, the U.S. Food and Drug Administration (FDA) approved the first implant of its kind designed to provide maintenance treatment of opioid dependence. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm503719.htm Probuphine, developed by Braeburn Pharmaceuticals utilizing Titan Pharmaceuticals’ continuous drug delivery system, is a small implant that is made from a mixture of ethylene-vinyl acetate and 80mg of […] Continue
On the heels of the release of the FDA’s guidelines for the development of generic formulations for abuse-deterrent opioid medications, the FDA Advisory Committees have weighed in on several proposed abuse-deterrent opioid medications. On April 26, 2016, the U.S. Food and Drug Administration (FDA) approved a new long-acting opioid medication designed for the management of […] Continue
The National Survey on Drug Use and Health (NSDUH) showed that in 2012 about 2.1 million Americans were addicted to opioid pain medications, roughly 467,000 addicted to heroin and about 2.5 million Americans with opioid use disorder but receiving legitimate prescriptions. According to the CDC, opioids were involved in 16, 235 deaths in 2013 and […] Continue
On Tuesday, March 22, 2016, the U.S. Food and Drug Administration (FDA) announced it will now require a black box warning on all immediate-release opioid medications. This warning will address issues regarding the risks of abuse, addiction, misuse, overdose and death. The FDA had indicated that immediate-release opioid medications should be reserved for individuals with […] Continue