April 2023
PDR Drug Update
- Lead Story
- Latest FDA News
- FDA Recalls
- Labeling Updates
Alternative CGRP Option for Migraineurs
With over 39 million individuals in the US and over one billion individuals globally affected by migraines, the disease ranks as the third top worldwide illness. Patients with migraines often must cope with intense, throbbing head pain lasting for hours or several days. Additional symptoms can accompany the pain of an attack, commonly nausea, vomiting, light or sound sensitivity, and visual disturbances known as auras. Quality of life for these patients can be strongly diminished. The treatment plan a provider determines will usually be based on the frequency and severity of the headaches, if any additional symptoms occur, and any other medical conditions the individual has. Mild-to-moderate migraine attacks are typically addressed with analgesics such as acetaminophen and NSAIDs. Moderate-to-severe attacks are managed with migraine-specific treatment, including oral triptans. Triptans result in the constriction of blood vessels. They are sometimes not tolerated by individuals and should be avoided in those with a medical history of, or who are at risk for, stroke, artery disease, or cardiovascular disease.
In March 2023, a new approval was granted in the CGRP receptor antagonist drug class, which can give a promising alternative for migraine patients. The CGRP pathway has been targeted as having a significant role as a source for migraine pain. Research has discovered elevated CGRP levels in patient blood serum during and between migraine attacks, appearing in plasma, saliva, and tears. Medications that act on CGRP receptors are effective for treating migraine, and the newest approval provides a quick and reliable delivery method for such an antagonist. Zavzpret (zavegepant) has been approved for the acute treatment of migraine with or without aura in adults. Zavzpret is not indicated for the preventive treatment of migraine. Its recommended dose is 10mg as a single spray in one nostril, as needed, with one dose being the maximum for a 24-hour period.
Zavzpret offers some unique differentiators from other medications used to treat migraine. It does not have the complication of cardiovascular risk that triptans do, making it a favorable alternative for certain patients who cannot take triptans. Another desirable feature is that it is dispensed as a nasal spray. Sprays can be absorbed faster by the body, bringing the beneficial effect of the medication to patients more quickly. Clinical trials for Zavzpret showed its ability to reduce the pain from migraine attacks in 15 minutes. Since many migraine patients experience nausea and vomiting along with their attacks, having access to a non-oral medication can be a relief. Gastroparesis is also known to be present in migraine patients. Hence, the nasal spray dispensing of Zavzpret is favorable as it allows for quicker absorption of the drug, which is especially helpful for patients who may have slowed gut function.
Although there is no cure for migraines, new therapies such as Zavzpret continue to emerge that are helpful new additions to the existing options for migraine management. Hopefully, as advancements in migraine therapies continue, patients will experience less debilitating and less frequent migraines, and consequently, the quality of their lives will improve. Stay informed about emergent drug information, including treatment options for migraine, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, mobilePDR, available for free from your favorite app stores.
FDA New Approvals
Joenja
The FDA has approved Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients aged 12 years and older. Joenja, an oral, selective PI3Kδ inhibitor, is the first and only treatment approved in the US for APDS, a rare and progressive primary immunodeficiency. Learn more about Joenja
Narcan OTC
The FDA has approved Narcan (naloxone HCl) 4mg nasal spray for OTC, nonprescription use. This is the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Learn more about Narcan
Nelarabine
The FDA has approved nelarabine for injection (SH-111) for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, providing patients with an alternative to a treatment that has historically been in shortage. Learn more about nelarabine
Rezzayo
The FDA has approved Rezzayo (rezafungin) for injection for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Rezzayo is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. Learn more about Rezzayo
Zynyz
The FDA has approved Zynyz (retifanlimab-dlwr), a programmed death receptor-1–blocking antibody indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Learn more about Zynyz
FDA New Indications
Evkeeza
The FDA has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first angiopoietin-like 3 inhibitor treatment indicated for children as young as 5 years old to control dangerously high levels of low-density lipoprotein cholesterol caused by HoFH. Evkeeza was initially approved as an adjunct to other lipid-lowering therapies in those aged 12 years and older with HoFH in February 2021. Learn more about Evkeeza
Hyqvia
The FDA has approved an expanded use of Hyqvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase) for treatment of primary immunodeficiency (PI) in children aged 2-16 years. Hyqvia is the only subcutaneous immune globulin infusion that can be administered once a month and was first approved in the US in 2014 for the treatment of PI in adults. Learn more about Hyqvia
Keytruda
The FDA has granted full approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Learn more about Keytruda
Keytruda with Padcev
The FDA has approved Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Learn more about Keytruda with Padcev
FDA Recalls
Ascend Laboratories Dabigatran Etexilate
Ascend Laboratories is voluntarily recalling dabigatran etexilate capsules USP 75mg and 150mg to the consumer/user level due to the presence of a nitrosamine, N-nitroso-dabigatran, above the established acceptable daily intake level. As of the alert date, Ascend Laboratories had not received any reports of adverse events related to this recall. Learn more about the Ascend Laboratories dabigatran etexilate recall
Camber Pharmaceuticals Atovaquone
Camber Pharmaceuticals is voluntarily recalling lot # E220182 of atovaquone oral suspension, USP 750mg/5mL, to the consumer/user level, due to the potential Bacillus cereus contamination in the product. Learn more about Camber Pharmaceuticals atovaquone
Jarman’s Midwest Cleaning Systems Cleaning Solutions
Jarman’s Midwest Cleaning Systems is voluntarily recalling all lots of alcohol antiseptic 80% topical solution hand sanitizer non-sterile solution, Soft Hands alcohol antiseptic 80% topical solution hand sanitizer non-sterile solution, and isopropyl alcohol antiseptic 75% topical solution hand sanitizer non-sterile solution, to the consumer level. FDA testing found the presence of methanol. Learn more about Jarman’s Midwest Cleaning Systems cleaning solutions
Labeling Updates
- Key
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Boxed Warning
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Other Warnings*
*Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications
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Updates to Indications/Dosage
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Other Updates†
†Other labeling changes; added to PDR database
No Depakote ER boxed warning | No Depakote ER Other Warnings | Depakote ER (divalproex sodium) | ||
No Depakote Sprinkle Capsules boxed warning | Depakote Sprinkle Capsules (divalproex sodium) | |||
No Nurtec ODT boxed warning | No Nurtec ODT Indications/Dosage Updates | Nurtec ODT (rimegepant sulfate) |
No Ubrelvy boxed warning | No Ubrelvy Indications/Dosage Updates | Ubrelvy (ubrogepant) | ||
No Verquvo boxed warning | No Verquvo Other Warnings | No Verquvo Indications/Dosage Updates | Verquvo (vericiguat) |