FDA Approves Diazepam Nasal Spray and Fast Tracks New Drug for Spinal Cord Injury

FDA Approves Valtoco for Seizure Activity

The FDA has approved Valtoco® (diazepam nasal spray), a benzodiazepine for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern.

Seizure activity may present in injured worker populations that have experienced head injuries, including traumatic brain injury, which could require the prescribing of antiepileptic drugs.

Valtoco dosage is dependent on a patient’s weight and age. Dosage strengths include 5 mg, 7.5 mg, and 10 mg doses. Valtoco 5 mg and 10 mg doses are administered as a single spray intranasally into one nostril. Administration of 15 mg and 20 mg doses requires two nasal spray devices, one spray into each nostril.

According to the FDA-approved drug label, no more than two doses should be used to treat a single seizure episode, and Valtoco may be used to treat no more than one seizure episode every five days, and no more than five episodes per month.

Adverse reactions include somnolence (drowsiness), headache, and nasal discomfort. As a benzodiazepine, serious consideration should be taken if the patient is currently taking an opioid medication, as this drug-drug interaction caries serious risk.

FDA Fast Tracks Novel Therapy for Spinal Cord Injury

The FDA has granted Fast Track designation to AXER-204, a human fusion protein, for the potential treatment of chronic spinal cord injury.

AXER-204 is believed to stimulate the growth of never fibers, which could assist with the recovery of spinal cord injury. Phase 1 and 2 clinical trials are both currently underway. The Phase 1 trial is a multicenter, open-label, single ascending dose study in participants with chronic cervical spinal cord injury, involving four cohorts of six patients, each of whom will receive the same dose of AXER-204.

The Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in chronic cervical spinal cord injury. Up to 24 patients will randomly receive AXER-204 or placebo, with dose level and dose frequency dependent on outcomes from the Phase 1 trial.

By granting this medication a Fast Track designation, the FDA will increase communication with the drug developer and review portions of the NDA ahead of submission, giving this drug a leg-up in the approval process.


Tags: Voltoco, diazepam, nasal spray, seizure, benzodiazepine, spinal cord injury, FDA, fast track, clinical trials


4 Regulatory Trends to Watch Out for in 2020

Healthesystems keeps track of regulatory developments all year, delivering weekly Regulatory Recap emails to inform workers’ comp professionals of industry updates.

Having reflected on the biggest regulatory trends of 2019, while also keeping a close eye on what topics have gained traction lately, it appears that four major trends will see significant development in 2020. This will include:

  • Marijuana’s growing acceptance as a treatment option in certain clinical areas
  • Employee classification in the gig economy
  • More state formularies
  • The impact of artificial intelligence

Click here to learn more about these trends, and why they matter to workers’ comp.


Tags: Regulatory, marijuana, employee classification, misclassification, gig economy, formulary, AI, artificial intelligence


WCIRB Publishes Physical Medicine Report

The Workers’ Compensation Insurance Rating Bureau (WCIRB) of California released Physical Medicine Treatments and Their Impact on Opioid Use and Lost Time in California Workers’ Compensation, which analyzes the impact physical medicine has on opioid utilization.

Following a 2019 study on high-risk opioid use that found physical therapy (PT), acupuncture, and chiropractic care were consistently and significantly utilized more on claims involving lower doses of opioids, this report was drafted to find further patterns and trends in physical medicine cost and utilization.

This new report analyzed over 1.5 million claims that had a work-related injury and at least one medical service paid in the California workers’ comp system from 2013-2018. According to the study, concurrent increases in physical medicine costs along with sharp declines in utilization and payments for opioids suggest that physical medicine may have been used to substitute for opioids used to control pain.

Over 170,000 claims had a soft tissue injury to the shoulder, back, neck or knee from 2013-2017, and more than 50% involved at least one physical medicine service.

According to the report, the average medical payment for physical medicine continued to rise from 2013 through 2018, contributing to a growing proportion of the total medical paid per claim (8% to 11%) as well as the medical paid for physician services per claim (16% to 25%). Overall, the share of total medical payments for physical medicine increased 75% from 2013-2018.

The report found that soft tissue injury claims involving PT during the first 30 days of the initial medical visit were less likely to initiate opioid use within one year of the injury, compared to similar claims without early PT. Between 2015 and 2017, utilization of claims involving early utilization of PT were found to have significantly lower odds of opioid use by about 14% on average.

And while chiropractic care was less frequently used on soft tissue injury claims, its early use was found to be associated with a significantly lower probability of opioid use. Early chiropractic care within the first 30 days of injury was associated with 16% lower odds of opioid use.

Among soft tissue injury claims that had at least one opioid prescription within one year of the injury, those with early PT had, on average, significantly lower doses of opioids prescribed, by 23%, than similar claims without early PT.

The study states that legislation which removed requirements for prospective utilization review (UR) for certain medical services provided within 30 days of injury, including physical medicine, may have contributed to increases in physical medicine utilization and decreases in opioid utilization.


Tags: WCIRB, California, physical medicine, physical therapy, PT, chiropractic


Marijuana Bills Could Create Protections for Employment Discrimination

Last July, Healthesystems reported that both New York City and the state of Nevada passed regulations to protect prospective employee’s rights to use marijuana.

In both cases, employers were prohibited from denying employment to a prospective employee over the presence of marijuana in a drug screening test, with exceptions for certain first responders, federal positions, and safety-sensitive occupations.

Now, as legislative sessions begin again, three more states have introduced bills that, if passed, would introduce similar protections across the country.

The Colorado General Assembly introduced House Bill 1089, which prohibits an employer from terminating an employee for the employee’s lawful off-duty activities, even if those activities are not lawful under state law.

The bill’s text specifically calls out marijuana, stating that though marijuana is regulated similar to alcohol in the state, employers can still fire employees over off-duty use, claiming such procedure is an unlawful prohibition.

Meanwhile, the Washington State Legislature introduced House Bill 2740, which would make it unlawful for any employer in the state to fail or refuse to hire a prospective employee due to a drug screening that shows positive results for marijuana use. Exceptions to this bill would include:

  • The hiring of firefighters, EMTs
  • Employment that requires the operation of a motor vehicle and for which federal or state law requires the employee to submit to drug tests
  • Positions of employment funded by a federal grant
  • Employment tied to federal contracts that require specific drug-free workplace policies

Furthermore, the West Virginia Legislature introduced House Bill 4186, which would remove marijuana as a tested substance from the screening requirements of the West Virginia Alcohol and Drug-Free Workplace Act, essentially protecting marijuana users from termination or the denial of hiring when workplaces must obey the act and carry out drug screenings.

And in related news, New Jersey introduced Assembly Bill No. 1708, which would require workers’ compensation and personal injury protection to cover costs associated with medical marijuana. This bill would apply to patients that have tried at least one other type of treatment and found it to be unsuccessful, prior to qualifying for the state’s medical marijuana program.

If more states pass measures such as these, individuals could potentially work under the influence, leading to safety issues that could cause workplace injuries. For further information on marijuana’s impact on workers’ comp, download Healthesystems’ white paper, Clearing the Air: Marijuana Considerations for Workers’ Comp.


Tags: marijuana, drug screen, Colorado, Washington, West Virginia, protection, hiring


An Opioid Snapshot for 2020

As awareness surrounding the opioid epidemic has grown over the last several years, different organizations, regulatory associations, prescribers, and the general public have taken many collective steps to impact opioid utilization, and this has led to significant changes.

In fact, Healthesystems recently partnered with Risk & Insurance® to conduct a workers’ comp industry insight survey, and among the various insights uncovered, it was found that while opioids are still prevalent and problematic, industry concern surrounding the epidemic has slightly decreased.

Such changes are based on recent data findings from key institutions. The Centers for Disease Control and Prevention (CDC), reported that opioid prescribing peaked from 2010-2012 and has been declining ever since, with a 19% reduction in annual prescribing from 2006-2017.

Furthermore, the Workers’ Compensation Research Institute (WCRI) examined 575,000 claims across 27 states, which represented 37-72% of workers’ comp claims in each state, and found that opioid prescribing dropped significantly in comp claims. In Illinois the decrease came to 8%, while in California it came to 25%. Approximately 17 states saw MME decrease by 30% or more, and three states saw 50% decreases.

Not only have prescribers shifted their practices, but so have regulatory authorities. The Department of Health and Human Services published an opioid tapering and discontinuation guideline last year, and various lawsuits mounted against opioid manufacturers have resulted in multi-million dollar settlements and rulings, the latest just this January resulting in $8.75 million, pushing the state of Oklahoma to launch three more suits against distributors.

In fact, an FDA panel voted 27-0 against the approval of a new opioid due to the potential for abuse, causing the manufacturer to withdraw the drug for consideration and cease development.

The tide appears to finally be changing. And while there has been much progress, there are still concerns for which we must remain vigilant.

The CDC recently issued a new data brief on drug overdose deaths, and while overdose deaths from natural and semisynthetic opioids like oxycodone and hydrocodone slightly decreased from 2017-2018, overdose deaths involving synthetic opioids like fentanyl increased 10%. Furthermore, the average number of days per opioid prescription continues to rise, with the CDC estimating an average of 18 days per prescription in 2017.

But as the strategies that have yielded such beneficial progress continue to evolve, it is certainly possible that even the rise of opioid overdose deaths related to synthetic opioids may soon receive the attention and strategies they deserve.

As a nation, and as an industry, we’ve come a long way in addressing the opioid epidemic, and 2020 could very well be a landmark year for changing the narrative in workers’ comp.


Tags: opioids, CDC, HHS, WCRI, overdose death, opioid prescribing