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
The U.S. Food and Drug Administration (FDA) approved Auvelity™ extended-release tablets on August 18, 2022. Indicated to treat adults who have major depressive disorder (MDD), it combines 45 mg of dextromethorphan, which is an N-methyl D-aspartate (NMDA) receptor inhibitor, with 105 mg of bupropion, which interferes with the activity of certain blood components. The result is higher blood levels of dextromethorphan and a longer duration of its effectiveness. In contrast to other current oral antidepressants, which may take several weeks to reach full effectiveness, Auvelity acts more quickly. In clinical studies comparing it to either placebo or bupropion, alone, it showed more positive effects at one week after the first dose and effectiveness lasted over the six-week long study periods.
Auvelity was approved under the FDA’s Breakthrough Therapy and Priority pathways. Its launch is planned for the fourth quarter of 2022, but the price is not yet determined.
Impact to Workers’ Comp
While depression isn’t the most common indication in workers’ compensation, any new antidepressant has the potential to impact a compensable claim. For any questions about the use of Auvelity, antidepressants, 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 |
---|---|---|---|
Bupropion/Dextromethorphan (Auvelity™) | Antidepressant | Major Depressive Disorder | Launch pending. Approved August 18, 2022. |
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 |
---|---|---|---|
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 |
---|---|---|---|
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 |
Nebivolol (Bystolic®) | Beta Blocker | Beta Blocker | September 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. |