Showing posts with label MIGRAINE. Show all posts
Showing posts with label MIGRAINE. Show all posts

Wednesday, March 11, 2020

FDA Approves Reyvow (lasmiditan), the First Serotonin (5-HT) 1F Receptor Agonist for the Acute Treatment for Migraine

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Reyvow (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. Reyvow has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).

Lasmiditan skeletal.svg

"Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack. There is a substantial unmet need for new acute treatments for migraine, like Reyvow, which is why we are proud of today's approval and Lilly's continuing contribution to the migraine community," said Gudarz Davar, M.D., vice president, neurology development, Lilly Bio-Medicines. "New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine."
As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for Reyvow. Abuse potential refers to the likelihood that abuse will occur with a particular drug product or substance with CNS activity. Consistent with the FDA's guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of Reyvow were associated with less drug liking when compared to alprazolam, but more than placebo. The recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of today's FDA approval, after which Reyvow will be available to patients in retail pharmacies.
"As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating," said Jan Brandes, M.D., MS, FAAN, assistant clinical professor, Department of Neurology, Vanderbilt University. "With new science comes new hope. Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like Reyvow is an important development for physicians and the patients we treat.
The New Drug Application (NDA) for Reyvow included data from two Phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of Reyvow for the acute treatment of migraine in adults. Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom (MBS; patient selected from nausea, sensitivity to light, or sensitivity to sound) at two hours following administration of Reyvow in comparison to placebo. Treatment emergent adverse events were generally mild to moderate and the most frequent included dizziness, fatigue, paresthesia (tingling or numbing sensation on the skin), sedation (sleepiness or drowsiness), nausea and/or vomiting and muscle weakness. See additional Important Safety Information below.
The Reyvow Phase 3 development program, including the open-label GLADIATOR study, involved more than 4,000 patients and the treatment of more than 20,000 migraine attacks.
"For over 25 years, Lilly has been committed to helping people affected by disabling headache disorders, investigating more than a dozen different compounds," said Patrik Jonsson, senior vice president and president, Lilly Bio-Medicines. "The approval of Reyvow is an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens."

Thursday, January 24, 2013

NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine

We know that, Sumatriptan (see structure) is a synthetic drug belonging to the triptan class, used for the treatment of migraine headaches. Structurally, it is an analog of the naturally occurring neuro-active alkaloids dimethyltryptamine (DMT), bufotenine, and 5-methoxy-dimethyltryptamine, with an N-methyl sulfonamidomethyl- group at position C-5 on the indole ring. On an 17, 2013, FDA has approved, Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN)....

Saturday, September 15, 2012

Tolfenamic acid appears to reduce esophageal tumors

A new study by researchers at MD Anderson Cancer Center Orlando finds that Tolfenamic acid (TA, see structure), a non-steroidal anti-inflammatory drug (NSAID), commonly used to relieve pain, inflammation and migraines has now been found to reduce esophageal tumors.

The study, led by Pius Maliakal, PhD and Riyaz Basha, PhD, researchers at MD Anderson Orlando's Cancer Research Institute, found that Tolfenamic acid prevented tumor growth and lessened the size of esophageal tumors in a rat model. Tolfenamic acid has been found to decrease certain proteins that are critical for cancer cell growth and the progression of esophageal tumors.

MD Anderson Orlando researchers are at the forefront of Tolfenamic acid research. It was this same research team that found that Tolfenamic acid inhibits tumor growth in pancreatic cancer. MD Anderson Orlando is poised to begin a new Phase I Clinical Trial for pancreatic cancer patients using Tolfenamic acid in a few months.

Further research will be required before Tolfenamic acid can be used as a safe and effective drug for esophageal cancer prevention. At present, this drug is an approved anti-inflammatory agent in Europe, South America and Asia, but is not yet approved for use in the United States.

Tolfenamic acid appears to reduce esophageal tumors

Saturday, June 30, 2012

Two-Drug Combo (naproxen and sumatriptan) Helps Teens With Migraines

A two-drug combination that relieves migraines in adults also works well in adolescents, new research indicates.
Because the combination of Imitrex (sumatriptan see structure left) and naproxen (structure right) sodium (Aleve and other brand names) isn't approved for use by the U.S. Food and Drug Administration for this age group, doctors must prescribe it "off label" to adolescents.
"There are no FDA-approved abortive [migraine] treatments for children," said Dr. Noah Rosen, director of the Headache Center at the Cushing Neuroscience Institute in Great Neck, N.Y. "This is the first really large-scale abortive treatment study for adolescents."
Migraines in children and adolescents are physiologically no different from migraines in adults, said Drexler, although migraines in younger people tend not to last as long.
The class of drugs known as triptans are the most studied, but none of those trials have shown a great benefit, possibly because of a large placebo response, the study authors wrote.

Friday, May 27, 2011

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

Levadex is designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (see above structure, DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines.
 MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults