February 2022 Report

February 2022 Report

New Drug and First Time Generic Report

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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 Now, the manufacturer has stopped distributing Zohydro® ER and the FDA rescinded approval for it effective in late February.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.

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