This blog series is devoted to better understanding the efforts our Federal government is undertaking to combat the opioid epidemic in America. Earlier this year, the Department of Health and Human Services (HHS) announced a five-part strategy that will be utilized to combat the opioid epidemic. In previous posts, we have focused on parts one […] Continue
Lyrica (pregabalin) is an analog of the neurotransmitter gamma-aminobutryic acid, or GABA. Within the brain and nervous system, GABA plays an important role in behavior, cognition and the body’s response to stressful situations. A deficiency in naturally-occurring levels of GABA has been linked to conditions such as schizophrenia, depression, anxiety and various sleep disorders. While […] Continue
On May 31st, the FDA approved Kitov Pharma’s application for Consensi™. Consensi is a unique combination product containing amlodipine, a calcium channel blocker used for the treatment of hypertension, and celecoxib, a non-steroidal anti-inflammatory used for the treatment of osteoarthritis. The product’s labeling will include a single indication for patients for whom treatment with amlodipine […] Continue
There can be little doubt that the opioid crisis has reached staggering levels. The Centers for Disease Control and Prevention (CDC) statistics from 2016 reveal that on average, opioids killed about 115 Americans every day.[1] Drug overdoses have become the leading cause of death in Americans under the age of 50, with opioids accounting for […] Continue
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