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
An opioid overdose reversal agent, nalmefene injection, is being reintroduced to the U.S. after being off the market since 2008. The FDA approved an application from Purdue Pharma on Feb. 8, 2022, for two mL single-dose vials that contain two mg of the solution. It is indicated to block, at least partly, the adverse effects such as respiratory depression of opioid drugs and their overdoses.
Nalmefene, which has a longer lasting effect than another opioid antidote, naloxone, can be injected intravenously (IV), intramuscularly (IM) or subcutaneously (SC). If no response is seen in about five minutes, a second dose can be given. Additional doses probably will not help if the first two do not prompt a response from the patient.
Impact to Workers’ Comp
Purdue plans to supply nalmefene to emergency treatment facilities beginning mid-2022. For any questions about the use of nalmefene, naloxone, or 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 |
|---|---|---|---|
| Nalmefene Injection | Opioid Agonist | Opioid Overdose | Launch pending. Approved February 8, 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. |
| Buprenorphine Depot Injection (Brixadi™) | Opioid Agonist | Treatment of Opioid Addiction |
FDA review pending. |
| Oxycodone (Aximris XR™) | Opioid Analgesic – Extended Release |
Pain | FDA review pending. |
Generic Pipeline
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Vilazodone (Viibryd®) | Antidepressant | Depression | Patent set to expire June 2022. |
| 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. |
Available in the Last 12 Months
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Celecoxib/Tramadol (Seglentis®) | NSAID/Opioid Agonist | Pain | March 2022 |
| Baclofen Oral Suspension (Fleqsuvy™) | Muscle Relaxant | Muscle Spasms | March 2022 |
| Celecoxib Oral Liquid (Elyxyb™) | NSAID | Migraine Headache Treatment | February 2022 |
| Naloxone Nasal Spray (Kloxxado™) | Opioid Antagonist | Opioid Overdose | August 2021 |
Newly Available Generics
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
|
Diclofenac Potassium (Zipsor®) Capsule |
NSAID | Pain | March 2022 |
| 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 |
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. |