by The pharmaceutical company Pfizer, known for producing one of the most important anti-covid vaccines in the world, announced that the United States Food and Drug Administration (FDA) gave its approval to a nasal spray for treat migraine.
This is a treatment called Zavzpret, whose phase 3 clinical trials had already shown good results. According to the information shared by the pharmaceutical company itself, during these studies the drug was shown to be “statistically superior” compared to placebo in reducing pain and symptoms two hours after being applied directly to the individuals’ nostrils.
“The pivotal study also demonstrated pain relief in as little as 15 minutes on a pre-specified secondary endpoint compared to placebo,” Pfizer noted.
The news gained international relevance, since the bulk of the treatments to combat migraine that have been authorized by health entities in different countries are limited to oral administration.
“The FDA approval of Zavzpret marks a significant advance for migraineurs who need to be pain-free and prefer alternative options to oral medications”said Angela Hwang, who serves as Pfizer’s chief commercial officer and president of global biopharmaceutical businesses.
“Zavzpret underscores Pfizer’s commitment to offer an additional treatment option to help people with migraines get relief and get back to their daily lives. Pfizer will continue to develop its migraine franchise to further support the billions of people around the world affected by this debilitating disease,” Hwang said.
As indicated by the pharmaceutical company through a press release, the FDA also supported its approval based on two randomized pivotal investigations, which are studies that are carried out at the request of the health authorities.. There, criteria such as efficacy, tolerance margin and safety of the drugs that are tested are evaluated.
“The pivotal phase 3 study, published in The Lancet Neurology found that Zavzpret showed broad efficacy by also demonstrating statistically significant superiority over placebo in 13 of 17 pre-specified secondary outcome measures, including early endpoints (for example, pain relief at 15 and 30 minutes and return to function). normal at 30 minutes), return to normal function at 2 hours, and long-lasting efficacy endpoints,” Pfizer said.
This treatment has made a good impression among doctors and has been a reason for hope for patients suffering from migraine, since the headaches caused by this health condition can greatly reduce their quality of life.
“When a migraine occurs, it has a significant negative impact on a person’s daily life,” said Kathleen Mullin, the associate medical director of the New England Institute of Neurology and Headache, who was also quoted in the Pfizer statement.
“Among my migraineurs, one of the most important attributes of an acute treatment option is how quickly it works. As a rapidly absorbed nasal spray, Zavzpret offers an alternative treatment option for people who need pain relief or are unable to take oral medications due to nausea or vomiting, so they can return to normal function quickly. ”, added the medical expert.
In addition, Pfizer noted that overall, clinical trial results showed that the nasal spray is safe for patients. Nevertheless, noted that just under 2% of patients experienced some adverse effects, including taste disorders such as dysgeusia (bad taste in the mouth) and ageusia (partial or total loss of taste).
Some patients also experienced other side effects such as nausea, vomiting, and discomfort in the nose.
“Zavzpret is contraindicated in patients with a history of hypersensitivity to zavegepant or any of its components. Hypersensitivity reactions, including facial swelling and urticaria, have occurred with Zavzpret in clinical studies,” Pfizer concluded.
