Mari Edlin

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 

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 has a preventive product currently under review by the FDA. Approval is expected in the third quarter of 2018. Lilly’s rivals are 

 in partnership with Novartis, the latter of which filed for approval last June.

Lilly also plans to submit an NDA to the FDA for 

, 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.

Preventive Treatment: Implications for Patients

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, 

“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.”

Preventive Treatment: Implications for Pharmacists

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 

Alex Peaslee, PharmD, drug information pharmacist for 

, a pharmacy benefits manager based in Appleton, WI, suggests that pharmacists hone their migraine management counseling skills and knowledge about the following:

Adverse reactions and an injection site reactions

How well the new drug is tolerated by patients

Prep work needed for a subcutaneous injection

Other migraine prevention techniques, such as regular eating and sleeping schedules  

However, he says patients targeted for galcanezumab have already tried different prophylactics and are familiar with their objectives and potential impact.

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 

, 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 

, while current triptans used to treat migraines bind to  

 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.

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. 

Articles

New drugs for acute migraines are almost ready for prime time. Here's what you need to know.

New Migraine Meds Pharmacists Need to Know About

With the explosive growth of nutraceuticals and their growing popularity among consumers, pharmacists have an opportunity to add to their skills and further cement their position in the healthcare industry as healthcare providers. But they must be a quick study. There are more than 29,000 different nutritional supplements on the market today, according to the FDA.

The U.S. market for nutraceuticals, which was $64.8 billion in 2015, is anticipated to increase at a compound annual growth rate (CAGR) of 5.3% from 2016 to 2024 and reach a value of $102.6 billion, according to 

 (TMR). These researchers also anticipate that competition will significantly grow as more competitors make their way into the field.

Nutraceuticals include dietary supplements, functional foods (probiotics and fatty acid-based foods), botanicals/herbals, 

vitamins/minerals, amino acids, proteins, and peptides that are derived from natural bioactive compounds. They add health benefits to the basic nutritional value found in foods and are primarily used to promote health and wellness or prevent and treat disease. 

While “nutraceuticals” and “dietary supplements” are often used interchangeably, the latter serves as the broader category. Dietary supplements have been marketed to address a large variety of ailments, from insomnia and poor digestion to low energy, joint pain, and immune health.

Seventy-six percent of more than 2,000 U.S. adults surveyed take dietary supplements-up five percentage points over 2016, according to the “2017 CRN Consumer Survey on Dietary Supplements” put out by the 

Vitamins/minerals are the most highly consumed supplement category-as found in earlier surveys-with 75% of survey respondents saying they have taken these in the past 12 months.

Specialty supplements (taken by 38% of respondents) are the second most popular category.

Other popular supplements are herbals/botanicals (taken by 29% of respondents), sports nutrition supplements (22%), and weight management supplements (15%).

Demand for liquid nutraceuticals is higher among consumers than other forms of nutraceuticals-with a 6.10% CAGR by 2024, according to TMR. The company also says functional foods are popular because they tie into health benefits of natural products.

Adults aged 55 and older report the highest percentage of supplement use at 74%, according to CRN’s 2016 consumer survey. But 70% of adults aged 18 to 34 say they take dietary supplements.

Baby boomers are looking to optimize foods with dietary supplements, says Andrew Dahl, CEO of 

, a research and development firm. They are also motivated by concerns over increasing costs of prescription drugs and by supplements’ preventive characteristics, says Yvette La-Garde, Chief Operating Officer for 

, which manufactures and sells a line of dietary supplements.

Mike Smith, MD, Director of Education for supplement supply company 

, says younger consumers are looking for  lifestyle and life-specific supplements such as those for heartburn, acid reflux, constipation, pain, and high blood pressure and cholesterol.

Overall, growth of nutritional supplements outpaced total store growth in the last year, with 5.8% year-over-year growth reaching a market total of $16 billion, according to Information Resources Inc. Total store growth was 1.2%, for a total market value of $757 billion, indicating dietary supplement sales grew at about five times the rate of total store sales in the last year.

Pharmacists can play an important role in helping consumers identify safe and effective supplements, says Marvin Moore, PharmD, President/Owner of The Medicine Shoppe in Two Rivers, WI. He advocates for consumers to buy products at pharmacies rather than online.

“As small, independent pharmacies, we spend time answering questions as best we can and do research to determine if products work and are efficacious. We can’t make promises about safety but if we carry a product, we believe in it and can study it,” Marvin Moore says.

He says his customers often read about supplements online and in ads and are curious about them and concerned over their safety. His best sellers are iron, calcium, multivitamins, and vitamin D.

Steve Moore, PharmD, Owner/Pharmacist, Condo Pharmacy in Plattsburgh, NY, (no relation to Marvin Moore), says dietary supplements comprise half of his total over-the-counter sales. He receives a fair amount of questions about supplements-especially because of his location in the upper Northeast where vitamin D deficiency is common in winter.

“Doctors often send patients to a pharmacist to seek information on the kinds of products available. This is a great role for pharmacists because we are the most accessible medical professionals,” Steve Moore says. “We are comfortable answering questions because we have responsibility for making the right recommendations when some supplements could cause harm.” Two examples: a magnesium supplement taken for sleep or muscle cramps could be risky for someone with a kidney problem, or too much vitamin E could harm those with cardiac issues.

If consumers are using several dietary supplements, pharmacists might need to perform a comprehensive medication review, in the same way they review prescription medications.

Duffy MacKay, ND (Doctor of Naturopathy), says conversations about adverse interactions between drugs and dietary supplements are an ideal opportunity for pharmacists to communicate with consumers. “In this way, pharmacists can participate in both sides of a drugstore; they can play a pivotal role when prescription drugs and dietary supplements are integrated,” says MacKay, who is the Senior Vice President of Scientific and Regulatory Affairs at CRN.

In general, most pharmacists have a baseline knowledge of nutraceuticals and know the most problematic interactions and side effects, according to the NCPA.

“There are some pharmacists who have chosen to learn about nutraceuticals at a very deep level and built a business model around their pharmaceutical and nutraceutical expertise. The average pharmacist, however, might not be as familiar with insights about subpopulations and specific products that are available,” an NCPA spokesperson says.

A 2015 study published in Healthcare examined the views of pharmacists regarding giving dietary advice to patients. It found that they perceive they have a role in the delivery of information about supplements and should recognize the value of referring patients to specialists, such as dieticians, and of accessing appropriate nutrition information.

John Pezzuto, PhD, is concerned that some pharmacists may not know enough about toxicity, interactions with prescription drugs, and possible overdosing, making it difficult for them to recommend nutraceuticals. “Pharmacists also might be too busy to answer questions and may find it difficult to know what to say,” says Pezzuto, who is Professor and Dean of the Arnold and Marie Schwartz College of Pharmacy and Health Sciences at Long Island University in New York.

) Education Standards require course work on natural products in all PharmD programs. 

ACPE has a curricular expectation that includes coverage of nutraceuticals and dietary supplements.  For natural products and alternative and complementary therapies, there should be evidence-based evaluation of the therapeutic value, safety, and regulation of pharmacologically active natural products and dietary supplements. Education should also include information about the cultural practices of practitioners and/or patients  and their potential impact on pharmacotherapy. ACPE also  has a database of continuing pharmacy education activities  on subjects such as herbal medicines and supplements.

“Our students certainly give voice to the need for more complete curricular coverage to meet consumers’ needs,” says Lucinda Maine, CEO and Executive Vice President, 

American Association of Colleges of Pharmacy

An authoritive source pharmacists can use for information on dietary supplement products and for verification of their quality is USP, she says. 

Answering consumers’ questions about nutraceuticals adequately and providing counseling could be a problem for pharmacists in a busy retail environment, acknowledges Dahl. “It could take up too much time and not be worth it to a store,” he says. “In addition, pharmacists are often cautious because they are worried about recommending products and don’t know about potential interactions with drugs a patient might be taking.”

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But, Pezzuto  says, pharmacists must find time to address public perceptions of products that claim to be natural. “People think natural equals safe but that’s not always true.”

One solution could be to follow Marvin Moore’s suggestion: Only carry nutraceuticals that you know and trust.

Learning more about popular dietary supplements could further cement pharmacists’ position in the healthcare industry, helping them gain recognition as healthcare providers.