The Food and Drug Administration has approved Pfizer’s migraine nasal spray as an instant pain relief for people suffering from it.
RELATED STORIES:Â FDA To Lift Blood Donation Restrictions On Gay Men And Allow Single Men To Donate
In a report by Fox News, Pfizer launched the medication named Zavzpret, a medication that blocks CGRPs, a protein released in the brain that triggers migraines. It is the first calcitonin gene-released peptide receptor antagonist nasal spray to be approved by the FDA. It was approved after two randomized, double-blind, placebo-controlled studies, as told by Pfizer in a statement.
“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications. Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.”
RELATED STORIES:Â Abbott Baby Formula Plant Reopens After Approval From FDA
The company said clinical trials proved effective in reducing pain within 15 minutes, and those suffering from migraines could resume normal activities within 30 minutes. However, it is intended to treat migraines and can last up to 48 hours. Pfizer emphasized that it is a treatment to help symptoms and not a cure. Additionally, it will be available as a prescription starting in July 2023 and used as an alternative for individuals who cannot handle pills or injections.
“The pivotal Phase 3 study published in The Lancet Neurology found ZAVZPRET showed broad efficacy by also demonstrating statistically significant superiority to placebo across 13 of 17 prespecified secondary outcome measures, including early time point endpoints (e.g., 15 and 30-minute pain relief and return to normal function at 30 minutes), return to normal function at 2 hours, and durable efficacy endpoints (e.g., 2-24 and 2-48 hour sustained pain freedom and sustained pain relief).”
Social media users who deal with migraines said they had mixed feelings about the medication due to the duration of pain relief,
I’m all for modern medicine. But, idk about this one.. https://t.co/4gv5eYwDdM
— KM (@KGJ26) March 10, 2023
Sounds cool. Can’t get the migraine meds that works best for me now cause my insurance thinks I should pay $500 for it 🙃 https://t.co/3NfUNfkRtW
— 💜 (@NesstheDiva) March 10, 2023
That would be great since my 14 yr old usually vomits any meds they take when they get a migraine.
— Karen R (she/her) (@karrin21262) March 10, 2023
This would be a game changer for those who suffer from migraines. No medicines has worked neither did Botox, I hate going to urgent care for toradol.
— Julie (@MayorOfSnark) March 10, 2023
If this thing works for migraines, I will build Pfizer a monument the size of the Empire State Building! https://t.co/PXspc5rXgm
— R (@My_Minds_Mess_) March 10, 2023
Some of the side effects included taste disorders, nasal discomfort, vomiting, and skin rashes for people with hypersensitivity.
“ZAVZPRET was well tolerated in clinical trials. The most common adverse reactions reported in at least 2% of patients treated with ZAVZPRET and at a frequency greater than placebo were taste disorders (includes dysgeusia and ageusia), nausea, nasal discomfort and vomiting. ZAVZPRET is contraindicated in patients with a history of hypersensitivity to zavegepant or to any of its components. Hypersensitivity reactions, including facial swelling and urticaria, have occurred with ZAVZPRET in clinical studies.”