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New drugs for acute migraines are almost ready for prime time. Here's what you need to know.
Some people would give anything for a drug that could stave off a migraine, and they may get their wish by this summer.
Four drug companies have published positive data for Phase 3 trials for galcanezumab, a monoclonal antibody that is the first migraine-specific preventive medication. It is self-administered subcutaneously once monthly (as opposed to daily doses with current drugs), and targets the calcitonin gene-related peptide (CGRP) molecule that plays a role in this neurological condition.
One in seven U.S. adults report having migraines or severe headaches, according to the National Health Interview Survey. Due to a lack of effective drugs to prevent migraines, nearly 80% of migraine sufferers discontinue their current medication, whether prescription or OTC remedies, as reported in the Specialty Pharmacy Continuum’s January/February 2018 issue.
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Eli Lilly has a preventive product currently under review by the FDA. Approval is expected in the third quarter of 2018. Lilly’s rivals are Alder Biopharmaceuticals, Teva Pharmaceuticals, and Amgen in partnership with Novartis, the latter of which filed for approval last June.
Lilly also plans to submit an NDA to the FDA for lasmiditan, a serotonin receptor agonist for acute treatment of migraines in the second half of 2018. Eric Pearlman, MD, medical lead for the U.S. Migraine Platform for Eli Lilly, says the company is basing its submission on results from two Phase 3 studies, completed Phase 2 studies, clinical pharmacology studies, and an ongoing, long-term safety study. No other manufacturers have developed a similar product.
Over a 12-month treatment period, galcanezumab was associated with a statistically significant reduction in the number of monthly migraine headache days with both doses (5.6 days for 120 mg and 6.5 days for 240 mg). There was no clinically meaningful difference in the rate of adverse events between both dosing groups.
CGRP inhibitors are targeted biologic therapies aimed at preventing migraine attacks in patients who experience frequent migraines on a monthly basis, says Corey DeLuca, PharmD, manager of clinical pharmacy, Highmark Inc.
“Current FDA-approved migraine preventive therapies, such as beta-blockers and antiepileptic medications, as well as triptans, have other clinical uses beyond migraine prevention,” she says. This new class of therapy, DeLuca says, offers another preventive treatment option for patients, including those whose migraines that have not been well controlled despite trying other preventive therapies.
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The need for preventing migraines has not been met. Serious and frequent migraines can affect home, work, and social lives; and consume significant resources and indirect costs caused by absenteeism and presenteeism,” Pearlman says.
Although he says the industry has known about the effect of CGRP on migraines since the 1980s, and made attempts to develop products targeting it, manufacturers were concerned about safety and toxicity. “But with breakthroughs in technology and innovation, it has become easier to develop antibodies to bind with just CGRPs,” Pearlman says.
No price has been set for the new drug at press time; however, it is expected to be approximately $8,500 a year, says DeLuca. “As the CGRP inhibitors are new targeted biologic therapies, they are projected to be priced significantly higher than existing migraine preventative therapies, most of which are available as generics.”
Because galcanezumab is a new product, pharmacists will need to get up to speed on behalf of patients eligible for a prescription. “It is different from other biologics because it doesn’t interact with the immune system, so it has a different side effect profile: pain and/or reactions at an injection site for a limited time. Fewer than 2% of patients have discontinued the drug due to side effects,” Pearlman says.
The administration of galcanezumab is the same pen as the one used with an injection of Eli Lilly’s immunotherapy drug, Taltz (ixekizumab).
Up next: What pharmacists can do
Alex Peaslee, PharmD, drug information pharmacist for Navitus, a pharmacy benefits manager based in Appleton, WI, suggests that pharmacists hone their migraine management counseling skills and knowledge about the following:
However, he says patients targeted for galcanezumab have already tried different prophylactics and are familiar with their objectives and potential impact.
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Peaslee warns pharmacists to be aware of the overuse of migraine medication taken daily by episodic and chronic populations. “These therapies could cause more migraines, and no one wants to be responsible for that,” he says.
Randy Vogenberg, PhD, RPh, FASHP, a principal with the Institute for Integrated Healthcare, Greenville, SC, says patients are likely to ask about how the new products differ from current prescription therapies and OTC products. “Long-time migraine patients will be more familiar with taking medication for preventing or minimizing migraines versus younger or newly diagnosed patients,” he says.
“As these biologic products will likely be expensive and subject to managed care coverage restrictions, pharmacists will need to educate their patients on their proper use by subcutaneous injection; potential for any side effects or other contraindications during use; need for adherence; and maintaining the preventative effect of CGRPs versus acute medications for a migraine,” says Vogenberg, who believes the new type of migraine drug will represent a significant improvement in quality of life.
Lilly's lasmiditan, a first-in-class molecule taken orally, selectively binds to receptors 5-HT1F, while current triptans used to treat migraines bind to 5-HT1B and 5-HT1D serotonin receptors. Lasmiditan is prescribed in 50 mg, 100 mg, or 200 mg doses. Its mechanism of action does not include the vasoconstrictor activity associated with some migraine therapies.
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SPARTAN, a Phase 3 randomized placebo-controlled global trial evaluating the safety and efficacy of the three available doses for lasmiditan, confirms results from the earlier SPARTAN study. Two hours following a first dose, there was a greater percentage of migraine-pain-free patients-28.6% at 50 mg, 31.4% at 100 mg, and 38.8% at 200 mg-compared to a placebo (21.3%).
Two hours following the first dose, there was also a greater percentage of patients who were free of symptoms, such as nausea and sensitivity to sound and light, for the three doses, ranging from 40.8% to 48.7%, respectively, compared to a placebo.