FDA Approves Two New Opioids, New Dose for Narcan Nasal Spray

The FDA recently approved three different drugs that impact workers’ compensation, two of which are extended-release opioids, the other a new dosage strength of Narcan, a nasal spray formulation of the opioid overdose reversal agent naloxone.

Arymo ER

Arymo ER (morphine sulfate) extended-release tablets were approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate.

Arymo ER was originally formulated to be abuse-deterrent, but the FDA declared that it cannot be concluded that Arymo ER has physical and chemical properties that are expected to reduce abuse via the oral route.

Like other opioids, Arymo ER comes with many risks such as addiction, abuse, and misuse. Extended-release opioids such as Arymo ER come with greater risks of overdose and death, and should only be used for patients where alternative treatments options are ineffective.

For more information, read the FDA’s approval letter, or the approved drug label.

Vantrela ER

Vantrela ER (hydrocodone bitartrate) extended-release tablets were approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Vantrela ER is formulated with physiochemical properties intended to make the tablet more difficult to manipulate for misuse and abuse through oral, intranasal, and intravenous routes of administration. This abuse-deterrent technology is expected to reduce, but not totally prevent, abuse and misuse of Vantrela ER.

As with any opioid, Vantrela ER comes with potential risks such as addiction, abuse and misuse, even when used at recommended doses. These risks can lead to overdose, respiratory depression and death, and extended-release opioids such as Vantrela ER come with an even greater risk of these adverse events. Extended release opioids should only be used for patients where alternative treatment options are ineffective.

For further information, read the FDA’s approval letter, or the approved drug label.

New 2mg Dose for Narcan Nasal Spray

Narcan nasal spray (naloxone hydrochloride), a drug indicated for the emergency treatment of a known or suspected opioid overdose, has received FDA approval for a new 2mg dose.

The new 2mg dose is indicated for restricted use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. Narcan nasal spray was originally approved in November 2015 in a 4mg dose.

Narcan nasal spray is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. In opioid-dependent patients it may precipitate opioid withdrawal.

Narcan nasal spray is not a substitute for emergency medical care. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of Narcan nasal spray.

For more information, read the FDA’s approval letter, or the approved drug label.

Tags: Opioid, Opioids, Narcan, Naloxone, Drug Alert

Naloxone: The Path to Increased Patient Access

Naloxone has been used since 1971 to reverse opioid overdoses, a concern in workers’ compensation where opioids are commonly used to treat pain. Historically an emergency room drug, naloxone’s role in workers’ compensation has evolved as the drug becomes more accessible to patients due to new formulations, legislative action, and regulatory practices.

View the infographic to learn more.

Tags: Naloxone, Narcan, Evzio, Legislation

Brain-Computer Interface: New Research

The Public Library of Science (PLOS) released a new study that cites further progress in the use of brain-computer interface (BCI) in helping those who suffer from motor paralysis.

The practice of BCI involves capturing and recording electric activity in the brain (primarily through an electrode cap or an electrode implant in the brain), and using a computer system to translate that activity into a command which is sent to an external device.

In the PLOS study, patients suffered complete motor paralysis but still possessed intact cognitive and emotional processing, referred to as a “locked-in” state. The use of BCI allowed patients to answer yes-or-no questions by thinking their answer, whereupon a computer system read and translated their brain activity, displaying their answers on a computer screen and partially restoring their ability to communicate.

Beyond restoring basic communication, BCI has a wide variety of potential uses for patients with reduced mobility. While the technology is still evolving, BCI has managed to accomplish incredible feats in laboratory settings.

A series of experiments recorded in the Journal of NeuroEngineering and Rehabilitation allowed a paraplegic subject who suffered spinal cord injury to use BCI to pilot an exoskeleton by simply thinking about walking. Prior to the experiment, the patient’s brain activity was analyzed to identify the intent to walk. An electrode cap picked up on that activity, whereupon a computer system made the exoskeleton move, without the patient having to manually control the exoskeleton.

A different experiment used BCI to bypass a paralyzed patient’s spinal cord, sending electric signals from an implant in the brain to a special sleeve of electrodes around the patient’s arm, allowing him to move his hands with a fair degree of accuracy.

However, BCI currently has portability limitations. The use of wires and special equipment make the technology cumbersome to use in real-world settings. So far, the most prominent BCI technology available is the NeuroPace chip which was approved by the FDA in 2013. The NeuroPace uses BCI to scan the brain for electric activity related to epileptic seizures, sending a pulse to short-circuit the activity.

While this technology doesn’t currently have a significant impact in workers’ comp, it’s easy to imagine potential future applications, especially as breakthroughs in wireless BCI technology continue to develop. As BCI continues to evolve, it may very well play a role in providing newfound mobility to patients who have suffered terrible workplace injuries.

Tags: Brain-computer interface, BCI, Innovation, Restored function

More State Limits on Opioid Prescriptions?

New Jersey Governor Chris Christie issued Executive Order No. 219 which, among other objectives, calls for a limit on initial opioid prescriptions for acute pain.

The order tasks the state Attorney General with establishing the details of the limit, and the Attorney General has since addressed the New Jersey Board of Medical Examiners, pushing for a five-day limit.

While this piece of legislation is still in motion, it is one of many other opioid prescription limits proposed since the beginning of the year. Most states have proposed seven-day limits for initial opioid prescriptions, including Utah’s HB 50, Indiana’s SB 226, and Oregon’s HB 2114. And while no bill has been introduced yet, Maryland Governor Larry Hogan announced his intent to have a seven-day limit proposed as part of a larger opioid initiative.

These various initiatives continue momentum from last year, where several states successfully passed seven-day opioid prescription limits, including Massachusetts, Maine, Connecticut, and New York.

Before state-legislature sessions ended in 2016, more seven-day limits were in discussion in states including Alaska and Delaware, and so it appears that as state legislatures return to session, more of these bills are gaining momentum. This could lead to additional limits placed on initial opioid prescriptions, aimed at keeping opioid prescribing to short-term, acute treatment versus chronic.

Tags: Legislation, Opioids, Opioid prescription limits

Compound Drug Trends in Florida

The Florida Department of Financial Services just released the 2016 Results and Accomplishments Report for the Florida Division of Workers’ Compensation, taking note of trends in workers’ comp spend. Of particular note for payers are trends in compound drugs.

Overall payments for compound drug were on the rise from 2011 to 2013, starting at under $2 million in 2011, rising to over $9 million in 2013. However, they have been steadily decreasing as of 2013. This activity corresponds to a rise-and-fall in payments related to compounds dispensed by pharmacies.

While pharmacies seem to be dispensing fewer compounds than before, it appears prescribers are now dispensing more. In 2011, there was a total of 1,390 compound line-items billed by physicians, which has since increased to 5,575 in 2015.

In fact, from 2011 to 2015, total payments for physician-dispensed compounds have increased more than seven-fold. In 2011, payments for physician-dispensed compounds were just over $340,000, but in 2015 they reached almost $2.5 million.

While overall compounding practices look to be on the decline, prescriber activity has the potential to drive compound spending back up.

Tags: Compounds, Drug Spend