Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
Most recently marketed by Currax Pharmaceuticals, Zohydro® ER (hydrocodone extended-release capsules) has been removed from sale in the United States. A C-II controlled substance, it was FDA approved in 2013 as the only single-ingredient hydrocodone product for managing severe pain that needs continuous, long-term treatment and that has not responded to prior treatment. In 2015, it was reformulated to incorporate a proprietary technology called BeadTek™ that creates thick, sticky goo if the capsules are opened or crushed and the contents dissolved in liquids or solvents. Its use still was problematic, including lawsuits when some states attempted to ban its use at a state level. Now, the manufacturer has stopped distributing Zohydro® ER and the FDA rescinded approval for it effective in late February. Any patients who have been taking it should be switched to another pain reliever.
Impact to Workers’ Comp
Extended-release hydrocodone continues to be available as Hysingla™ ER and generics. While not the most utilized long-acting opioid, it is still of interest along with other opioids. For any questions about the use of Zohydro®, hydrocodone, or other opioids and potential relatedness to a claim, please consult with your myMatrixx pharmacist.
New Brand Drug Pipeline
Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
---|---|---|---|
Celecoxib/Tramadol (Seglentis®)
|
NSAID/Opioid Agonist | Pain | Launch anticipated in 2022. Approved October 19, 2021. |
Baclofen Oral Suspension (Fleqsuvy™) | Muscle Relaxant | Muscle Spasms |
Launch pending. Approved February 4, 2022. |
Baclofen Granules (Lyvispah™) |
Muscle Relaxant | Muscle Spasms | Launch pending. Approved November 22, 2021. |
Naloxone Injection (Zimhi™) | Opioid Antagonist | Opioid Overdose | Launch anticipated in 2022. Approved October 18, 2021. |
Celecoxib Oral Liquid (Elyxyb™) | NSAID | Migraine Headache Treatment | Launch pending. Approved May 5, 2020. |
Buprenorphine Depot Injection (Brixadi™) |
Opioid Agonist | Treatment of Opioid Addiction |
FDA review pending. |
Oxycodone (Aximris XR™) | Opioid Analgesic – Extended Release |
Pain | FDA review pending. |
Meloxicam/Bizatriptan | NSAID/Serotonin Agonist | Migraine Headache | FDA review pending. |
Nalmefene Injection | Opioid Antagonist | Opioid Overdose | FDA review pending. |
Generic Pipeline
Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
---|---|---|---|
Dabigatran (Pradaxa®) | Anticoagulant | Treatment/Prophylaxis of Deep Vein Thrombosis | First patent set to expire December 2021. Generic anticipated June 2022. |
Oxycodone HCl (Oxaydo®) | Opioid Agonist | Pain | Generic exclusivity anticipated in 2022. |
Apixaban (Eliquis®) | Anticoagulant | Treatment/Prophylaxis of Deep Vein Thrombosis | Generics approved December 23, 2019, but settlements expected to delay launch for at least a few years. |
Diclofenac Potassium (Zipsor®) Capsule | NSAID | Pain | Patent set to expire March 2022. |
Available in the Last 12 Months
Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
---|---|---|---|
Naloxone Nasal Spray (Kloxxado™) | Opioid Antagonist | Opioid Overdose | August 2021 |
Newly Available Generics
Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
---|---|---|---|
Naloxone HCl (Narcan®) Nasal Spray | Opioid Antagonist | Opioid Overdose | December 2021 |
Zolmitriptan Nasal Spray (Zomig®) | Serotonin Agonist | Migraine Headache Treatment | November 2021 |
Nebivolol (Bystolic®) | Beta Blocker | Beta Blocker | September 2021 |
Ibuprofen/Famotidine (Duexis®) | NSAID/H-2 Receptor Antagonist | Pain/Inflammation | August 2021 |
Pregabalin Extended Release (Lyrica® CR) | Anticonvulsant | Neuropathic Pain | April 2021 |
Hydrocodone Bitartrate (Hysingla™ ER) | Opioid Agonist – Extended Release | Pain | March 2021 |
Discontinuations & Withdrawals
Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
---|---|---|---|
Hydrocodone ER Capsules (Zohydro® ER) | Opioid Agonist | Pain | Manufacturer has stopped distribution and FDA has rescinded approval effective February 2022. |