FDA Reexamines Discontinued Drug for New Pain Applications
The FDA has granted priority review to Orphengesic Forte (aspirin; caffeine, orphenadrine citrate) a combination tablet meant to serve as a non-opioid alternative for the management of pain.
Orphengesic Forte was originally approved in 1998 for the relief of mild-to-moderate pain stemming from acute musculoskeletal disorders; this drug was approved after establishing bioequivalence with Norgesic Forte, a similar product with the same ingredients.
The ingredient orphenadrine citrate is an indirect skeletal muscle relaxant thought to work through central nervous system (CNS) depression, and there is little evidence supporting its use for chronic pain, though it may be helpful in patients with pain related to muscle spasms.
Both Orphengesic Forte and Norgesic Forter were later discontinued for uncertain reasons, but Galt Pharmaceuticals has submitted a Supplemental Abbreviated New Drug Application (SANDA) for Orphengesic Forte for updated pain management indications.
The FDA’s decision to grant the drug priority review will expedite the drug’s review process, indicating that Orphengesic Forte could have the potential to significantly improve the safety or effectiveness of the treatment of pain when compared to standard applications.
Orphengesic Forte has received an application decision date of August 14, 2019. As this drug could potentially find its way into workers’ comp, stakeholders should stay aware of clinical updates surrounding this product.
Tags: FDA, opioid, non-opioid, opioid alternative, priority review, orphengesic forte, orphenadrine citrate, pain
The Growing Utilization and Costs of Anticancer Medications
The Journal of the American Medical Association (JAMA) recently published a report that assessed the point-of-sale prices from 2010-2018 for orally administered anticancer drugs offered through Medicare Part D.
In 2013, only 12 anticancer drugs were covered by Medicare Part D, but by 2018 that number jumped to 54. Regarding cost, 48 out of 54 of those medications had monthly prices exceeding $10,000 per fill, and 21 had prices exceeding $15,000 per fill. Overall, the mean price per monthly fill in 2010 was $7,438, increasing to $13,992 in 2018. Since 2010, changes in per-fill price increased 40.4% overall.
While cancer is not the most common condition found in workers’ comp claims, it is prevalent enough that drug trends impacting cancer can make serious waves.
Occupational cancers can occur due to exposure to cancer-causing agents in the workplace environment, and it is estimated that 4% of all U.S. cancer cases are caused by occupational exposure. In fact, the Centers for Disease Control and Prevention (CDC) estimates that between 46,000-92,000 new U.S. cancer cases in 2012 were attributable to occupational exposure.
Furthermore, there is a strong legislative push for workers’ comp to cover more and more types of cancer for firefighters who are regularly exposed to known or suspected carcinogens on the job. If trends such as these continue to grow, comp programs will need to further familiarize themselves with cancer medications and create strategies to manage their utilization.
With pharmaceutical R&D growing more specialized, more and more oncology drugs are entering the market, dominating new drug approvals. And these drugs certainly have a market. IQVIA found that the number of patients on immune-oncology drugs doubled from 2016 to 2018, reaching 200,000. As this drug trend grows over time, it is very likely to impact workers’ comp.
Healthesystems has previously discussed how specialty drug trends, including the ongoing development of new cancer medications, are impacting workers’ comp, as well as treatment decision points for these specialty medications.
Tags: cancer, oncology, specialty drugs, specialty, specialty pharmacy, firefighter, JAMA, IQVIA
First Public Hearing for Cannabidiol (CBD) Products
The FDA recently held their very first public hearing on the regulation of cannabidiol (CBD) products, focused on obtaining scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
With medical marijuana legal in 33 states and the District of Columbia, there is much diversity in the regulation of marijuana products, and there has been much contention in the regulation of CBD products. While FDA-approved medications like Epidiolex have clear indications and usage guidelines, CBD products are not FDA approved.
CBD products are, in theory, supposed to lack THC, the compound responsible for the euphoric effects of marijuana, although depending on sourcing and quality, this may not in actuality be the case. Regardless, the belief that CBD products are not euphoric has led members of the public to believe these products are safer, despite a lack of clinical evidence.
Particularly relevant to workers’ comp, CBD products are often marketed to help relieve symptoms of all kinds, including muscle spasms, anxiety, depression, sleeplessness, and pain, meaning injured worker claimants could be using these products. And while initial research does indicate that CBD can offer certain clinical benefits for particular medical conditions, there has been an explosion of CBD products available on the market, and not only in smoke shops, but in health food stores and corner markets. These products are available in a myriad of formulations and marketed for a wide range of conditions.
CBD is available in oils, capsules and pills, gummies and other candies, edibles, topicals, sublingual picks, vape pens, bath bombs, pet treats, coffee, ice cream, energy drinks, beers and protein bars, vaginal suppositories, and much more. Furthermore, CBD is frequently advertised to benefit conditions such as post-traumatic stress disorder (PTSD), opioid addiction, brain injury, cancer, epilepsy, workout fatigue, high blood sugar, arthritis pain, anxiety, pain from menstrual cramps, insomnia, psychosis, and to slow the onset of Alzheimer’s or dementia.
And CBD products aren’t just available in smoke shops or alternative health stores; earlier this year CVS Pharmacies announced that they would carry CBD creams, sprays, lotions and salves in 800 stores across eight states. Shortly after that announcement, Walgreens announced that they would sell CBD creams, sprays and patches to 1,500 stores in nine states.
The FDA's public hearing involved testimony from stakeholders across academia, agriculture, consumers, health professionals, manufacturers, patients, and more. According to the opening statement from Acting FDA Commissioner Norman Sharpless, M. D., CBD products are being illegally marketed as drugs with intended therapeutic effects despite a lack of FDA approval or clinical testing, and as dietary supplements that have not been proven to be a safe food additive.
This trend is a cause for concern, as more clinical research is necessary to fully understand the impact CBD products can have on patients, especially if consumers combine multiple formulations, such as lotions with beverages or candy, oils, etc. Furthermore, as CBD can impact how the body breaks down other medications, there are potential drug-drug interactions to consider, along with other clinical uncertainties surrounding pregnancy and other conditions.
Though the FDA does not currently have a policy of enforcement discretion with respect to any CBD products, they have sent warning letters to various companies selling unapproved CBD products inappropriately, and the FDA has formed an internal working group to address existing data gaps.
While it will be some time before any definitive action is taken, the prevalence of CBD products has the potential to impact healthcare on a large scale, as patients may be mixing CBD products with various other medications. The scope of how prevalent CBD products are within injured workers populations remains to be seen, but considering these products’ popularity, it would be dubious to assume they have little-to-no impact on claimant populations.
Tags: marijuana, FDA, CBD, cannabidiol
FDA Proposes Fixed-Quantity Blister Packaging for Certain Opioids
In an effort to reduce excess drug supplies that can lead to opportunities for opioid misuse, abuse, addiction, and overdose, the FDA has proposed the requirement that certain immediate-release opioids be made available in fixed-quantity, unit-of-use blister packaging.
Citing new authorities granted to them by the passage of the SUPPORT for Patients and Communities Act, the FDA hopes to accomplish this goal by updating the REMS (risk evaluation and mitigation strategy) program for various opioids.
The FDA has reviewed published studies that compared the amount of opioid analgesics patients received to treat acute pain and compared it to the actual number of opioids used by such patients. Data suggests that using five, 10, or 15 count blister packaging reduces the number of unused opioids available for diversion, which could reduce the harm of the opioid epidemic.
Before making any policy decisions, the FDA is first soliciting public feedback on this proposal, asking for comments on:
The FDA will be accepting public comment through July 30, 2019.
Tags: FDA, opioid, blister, blister packaging, REMS