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
Axsome Therapeutics has announced the availability of Auvelity™ for the treatment of major depressive disorder in adults. Auvelity is a new combination drug containing dextromethorphan and bupropion that was approved by the FDA in August 2022. It was developed with the FDA Breakthrough Therapy designation for treatment of depression. In contrast to other antidepressants on the market, Auvelity acts more quickly – showing positive effects at one week.
Impact to Workers’ Comp
While depression is not the most common indication in workers’ compensation, it is still a noteworthy addition to the antidepressant class, which includes a variety of cost-effective alternatives already available. For any questions about the use of Auvelity, depression medications, 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. |