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Tag: Drug approvals

  • FDA Approves Fast-Acting Nasal Spray for Migraines, Pfizer Says

    FDA Approves Fast-Acting Nasal Spray for Migraines, Pfizer Says

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    March 10, 2023 — The FDA has approved a nasal spray that is expected to provide fast relief from migraines, the pharmaceutical company Pfizer said Friday.

    The drug zavegepant will be sold under the brand name Zavzpret and should be available in pharmacies by July 2023, the company said in a news release. The cost of the drug has not been revealed yet.

    Clinical trials published in The Lancet Neurology showed the nasal spray provided migraine relief within 15-30 minutes of use, with the relief lasting up to 48 hours in many patients, Pfizer said. About 1,400 people participated in the trials from October 2020 to August 2021. 

    “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” Kathleen Mullin, MD, associate medical director at New England Institute for Neurology & Headache, said in the Pfizer release.

    “As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”

    Pfizer says Zavzpret is the first product of its kind. It works by blocking the peptide receptors that cause inflammation that often comes with migraine.

    Pfizer said the drug was approved to treat acute migraine with or without aura – meaning a severe headache accompanied by uncomfortable symptoms such as dizziness, a ringing in the ears, zigzag lines in vision, or sensitivity to light.

    The American Migraine Foundation says 39 million Americans and 1 billion people worldwide live with migraine.

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  • Opponents file lawsuit targeting medication abortions

    Opponents file lawsuit targeting medication abortions

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    AUSTIN, Texas — Abortion opponents who helped challenge Roe v. Wade filed a lawsuit Friday that takes aim at medication abortions, asking a federal judge in Texas to undo decades-old approval of the drugs that have become the preferred method of ending pregnancy in the U.S.

    Even before the Supreme Court struck down the constitutional right to an abortion earlier this year, the use of abortion pills had been increasing in the U.S. and demand is expected to grow as more states seek abortion limits.

    The lawsuit was filed by the Alliance for Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. The lawsuit argues the U.S. Food and Drug Administration erred in approving the drugs mifepristone and misoprostol and overstepped its authority in doing so.

    Reached for comment, the FDA said it does not comment on pending or ongoing litigation.

    The lawsuit was filed in federal court in Amarillo, Texas. The state banned abortion after the Roe decision and is among the states where GOP lawmakers have banned mail delivery of the pills.

    The number of medication abortions has increased since regulators started allowing them and now account for roughly 40% of U.S. abortions. The medication can cost as little as $110 to get by mail, compared with at least $300 for a surgical abortion. Research has shown the pills are safe.

    However, people seeking abortion pills often must navigate differing state laws, including bans on delivery of the drugs and on telemedicine consultations to discuss the medication with a health care provider. And until Democrat Joe Biden became president, U.S. government policy banned mail delivery nationwide.

    Abortion medication is approved for use up to the 10th week of pregnancy. The pills may be taken in a doctor’s office or clinic, where patients sometimes have an ultrasound or lab tests beforehand.

    Mifepristone is taken first, swallowed by mouth. The drug dilates the cervix and blocks the effects of the hormone progesterone, which is needed to sustain a pregnancy.

    Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. The pill is designed to dissolve when placed between the gums and teeth or in the vagina. It causes the uterus to cramp and contract, causing bleeding and expelling pregnancy tissue.

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