April 2023 Report

April 2023 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

On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved Emergent BioSolutions to sell Narcan® (naloxone) 4 mg/0.1 mL nasal spray over- the-counter (OTC). Used to reverse the effects of an overdose with opioid drugs, Narcan soon will be available to buy online as well as at convenience stores, gas stations and other easily accessible locations. However, implementation of labeling changes and administrative procedures may take several months before the switch is finalized and the OTC product becomes widely distributed.

It is used in emergency situations to resuscitate patients who are in respiratory failure after an acute opioid overdose. By blocking opioid receptors, it displaces the opioid drug and decreases the negative effects of a drug overdose. Its directions are to administer one dose (one spray) as soon as an overdose is observed or suspected. Emergency medical help should be requested immediately after giving the drug. If needed, one additional dose (in alternating nostrils) can be given every two to three minutes until professional assistance arrives. Few side effects are associated with the use of Narcan, but some patients may experience temporary constipation, headache and/or nausea. It is not effective for overdoses of non-opioids, such as methamphetamine; but it is not harmful if administered accidentally to a person who has not overdosed – someone who is unconscious as a result of very low blood sugar, for example.

Harm Reduction Therapeutics, a non-profit organization, also has requested OTC status for its 3 mg/0.1 mL nasal spray naloxone, RiVive™. The FDA is expected to rule on this application on or before April 28, 2023. Higher strengths and other dosage forms of naloxone will remain prescription only. Pricing information for OTC Narcan is not yet known.

Impact to Workers’ Comp

Considering the potential of misuse and overdose, opioid antagonists are of interest in those claims where an opioid is prescribed.

For any questions about the use of naloxone, 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
Naloxone Nasal Spray Opioid Antagonist Opioid Overdose Launch pending. Approved March 2023.


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.


NSAID/Serotonin Agonist

Migraine Headache FDA review pending.
Naloxone Nasal Spray (RiVive™) Opioid Antagonist Opioid Overdose FDA review pending for OTC formulation.

Generic Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Cariprazine (Vraylar®) Antipsychotic Schizophrenia & Bipolar I Disorder Generic approved September 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

Newly Available Generics

Medication (Brand name) Drug Class Therapeutic Use Status Update
Lurasidone (Latuda®) Antidepressant Depression February 2023
Diclofenac Potassium (Cambia®) Solution NSAID Migraine Headache Treatment January 2023
Topiramate (Trokendi XR®) ER Capsule Anticonvulsant Neuropathic Pain January 2023
Dabigatran (Pradaxa®) Anticoagulant Deep Vein Thrombosis June 2022
Vilazodone (Viibryd®) Antidepressant Depression June 2022
Diclofenac Sodium 2% (Pennsaid®) Solution Topical NSAID Pain May 2022

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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