PLEASE NOTE: As 2022 comes to an end, this month’s report will be the last one of this year. Please look for the next New Drug & First Time Generic report in late January 2023.
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
Opiant Pharmaceuticals is developing an intranasal formulation of nalmefene, a long-acting opioid antagonist, for treating an opioid overdose. In early 2022, the FDA approved an injectable formulation of nalmefene for use in an emergency situation by a healthcare professional. Nalmefene has shown to reverse opioid intoxication for as long as eight hours, whereas naloxone, another commonly used opioid antagonist, requires monitoring and repeat dosing, as needed.
Impact to Workers’ Comp
Any opioid antagonist has potential to see utilization in workers compensation whenever an opioid analgesic is prescribed in a claim. For any questions about the use of nalmefene, opioid antagonists, 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 |
|---|---|---|---|
|
Ansofaxine |
Antidepressant | Major Depressive Disorder | FDA review pending. |
| 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/Rizatriptan |
NSAID/Serotonin Agonist |
Migraine Headache | FDA review pending. |
Generic Pipeline
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Cariprazine (Vraylar®) | Antipsychotic | Schizophrenia & Bipolar I Disorder | Generic approved September 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 |
|---|---|---|---|
|
Bupropion/Dextromethorphan (Auvelity™ |
Antidepressant | Major Depressive Disorder | October 2022 |
| Nalmefene Injection | Opioid Antagonist | Opioid Overdose | June 2022 |
| Baclofen Granules (Lyvispah®) | Muscle Relaxant | Muscle Spasticity | June 2022 |
| Naloxone Injection (Zimhi™) | Opioid Antagonist | Opioid Overdose | March 2022 |
| 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 |
Newly Available Generics
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Dabigatran (Pradaxa®) | Anticoagulant | Deep Vein Thrombosis | June 2022 |
| Vilazodone (Viibryd®) | Antidepressant | Depression | June 2022 |
| Diclofenac Sodium 2% (Pennsaid®) Solution | Topical NSAID | Pain | May 2022 |
|
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 |
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. |