Two new migraine prevention drugs show promise in small studies

migraines

There are few treatments available for the millions of people who suffer from migraines. New early-stage research offers new hope.

Studies presented Tuesday at the American Academy of Neurology’s annual meeting suggest that two new drugs may prevent migraines from happening.

“We’ve identified a new preventive treatment for migraines, something that reduces frequency, the number of attacks and severity of attacks, how bad the attacks are,” said Dr. Peter Goadsby, co-author of both studies and professor of neurology at Kings College, London and the University of California, San Francisco. “The results herald a new mechanism for the preventive treatment of migraines.”

That mechanism involves a protein called calcitonin gene-related peptide, or CGRP. CGRP is one of the key chemicals that causes the debilitating effects of a migraine. Both drugs work by blocking CGRP and therefore stopping the migraine from starting.

Both drugs are genetically engineered antibodies, a class of drug that’s been used in cancer treatments, but not yet for migraines.

The studies

One drug called ALD403 was tested for safety and efficacy in 163 patients, who typically spent 5 to 14 days per month suffering from migraines. Half got one 1000 mg intravenous dose of ALD403; the other half got a placebo. They were followed for 6 months. Within 2 months, patients on the drug saw a 66% reduction in the number of days they suffered migraines. They had on average nearly 6 more migraine-free days each month, compared to a 52% decrease (or just under 5 days) in those who got the placebo.

At 12 weeks, 16% of the patients who got the ALD403 were free of migraines. Those on the placebo were not.

The other promising drug is called LY2951742.  It too was found to be a safe and effective migraine treatment. In that study, 217 patients who had migraines 4 to 14 days per month got a 150 mg injection of LY2951742 every two weeks for 12 weeks. Those who got the shots saw about a 4-day reduction (or 63%) in the number of days with migraines, compared to a 42% decrease for those who got the placebo.

Results

Goadsby and Dr. David Dodick, co-authors of both studies, say this treatment is exciting because it’s entirely new and specific to migraines. Dodick, a professor of neurology at the Mayo Clinic and Chairman of the American Migraine Foundation, said no drugs targeting the treatment of migraines have been developed in the past 50 years.

“Presumably if you’re targeting the very protein responsible for an attack, you should have fewer side effects than (with) drugs which were designed to treat some other disease, and all drugs currently available for the prevention of migraines were designed to treat another disease.”

While there was no difference in the side effects reported by patients taking ALD403 and the placebo, patients getting LY2951742 reported side effects including pain at the injection site, abdominal pain and upper respiratory tract infections. Still, researchers say the drug is safe and well tolerated.

Implications

The studies are good news for migraine specialists such as Dr. William Young, a professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania.

“I’m impressed. We haven’t had a well proven preventive for episodic migraines like this since Topomax and Botox for chronic migraine,” says Young.

He says a quarter of his patients cannot hold down a job because of their migraines, and the condition is often stigmatized.

Why are there so few good treatments for migraines? Young, Goadsby and Dodick all point to the lack of funding of migraine research by the National Institutes of Health.

“There is an appalling, appalling under-resourcing of migraine research by government bodies such as NIH, Goadsby said. “There are 36 million Americans with migraines and on average the NIH spends about 30 US cents per migraine patient per year.”

Dr. Linda Porter, a Pain Policy Advisor at the NIH’s National Institute of Neurological Disorders and Stroke said “I would agree that we really do not spend a lot of research dollars on migraine and headache, but we do understand that it’s an incredibly significant health care problem and that chronic migraines can be very disabling for many people.”

In a statement to CNN, NIH characterized the funding issue as “a little bit complicated.”

“Our entire pain portfolio is $400 million dollars, that includes anything from osteoarthritis to cancer pain,” the statement said, “and so one of the difficulties that we have faced over the years in funding headache research is that the field of researchers is very small.”

Porter says more research dollars aren’t allocated to studying pain because of the few research applications they receive. “Over the past 10 years we have made great efforts to give funding priority to new or junior investigators in headache research to try to expand the field of researchers and thus expand the research portfolio.”

A lot of the basic science on the molecule (CGRP) which is used in these new drugs was funded by NIH, Porter said. She says the NIH is excited about these new studies.

But the drugs need to be tested in large scale clinical trials, and receive FDA approval, before patients can access them. Researchers estimate that’s at least 3 years away.

1 Comment

  • Vasu Murti

    Marijuana relieves the pain of migraine headaches!

    A pamphlet entitled 10 Things Every Parent, Teenager and Teacher Should Know About Marijuana produced by the Family Council on Drug Awareness tells us marijuana is not physically addictive. The 1980 Costa Rican study, the 1975 Jamaican study and the 1972 Nixon Blue Ribbon Report all concluded that marijuana use does not lead to physical dependency.

    The FBI reports that 65 to 75 percent of criminal violence is alcohol-related. On the other hand, Federal Bureau of Narcotics director Harry Anslinger testified before Congress in 1948 that marijuana leads to nonviolence and pacifism.

    In a message to Congress on August 2, 1977, President Jimmy Carter insisted: “Penalties against possession of a drug should not be more damaging to an individual than the use of the drug itself.”

    Drug Enforcement Administration (DEA) Law Judge Francis L. Young wrote on September 8, 1988: “Nearly all medicines have toxic, potentially lethal effects. But marijuana is not such a substance. There is no record in the extensive medical literature describing a proven, documented cannabis-induced fatality Marijuana, in its natural form, is one of the safest therapeutically active substances known to man.”

    ****

    Rose Evans, a widow and a grandmother, a pro-life Episcopalian fond of Buddhism, and editor and publisher of Harmony: Voices for a Just Future, a “consistent-ethic” periodical on the religious left, favors an end to marijuana prohibition.

    Rose Evans wrote in favor of the the legalization of marijuana for therapeutic (medicinal) purposed during the first half of the ’90s. Rose, born in 1928, considered it a crime that many of her elderly friends in her age group, suffering from numerous afflictions, were denied marijuana for medicinal purposes.

    After years of suppression by the government, the truth about medical marijuana is finally out. Dr. Tod Mikuriya, former director of marijuana research for the entire federal government, wrote in 1996: “I was hired by the government to provide scientific evidence that marijuana was harmful. As I studied the subject, I began to realize that marijuana was once widely used as a safe and effective medicine. But the government had a different agenda, and I had to resign.”

    Of all the reasons to legalize marijuana, the most compelling is its medical usage. Marijuana has a wide variety of therapeutic applications, and is frequently helpful in treating the following conditions:

    AIDS. Marijuana reduces the nausea, vomiting, and loss of appetite caused by both the ailment itself and as a side effect of treatment with AZT and other medicines.

    Asthma. Several studies have shown that THC acts as a bronchodilator and reverses bronchial constriction. Although conventional bronchodilators work faster than marijuana, THC has been shown to last longer and with considerably less risk.

    Arthritis and Other Autoimmune Diseases. In addition to its effectiveness in controlling the pain associated with arthritis, new evidence shows that marijuana is an autoimmune modulator.

    Cancer. Marijuana stimulates the appetite and alleviates nausea and vomiting, common side effects of chemotherapy treatment. People undergoing chemotherapy find that smoking marijuana is an anti-nauseant often more effective than mainstream medications.

    Chronic Pain. Marijuana alleviates the debilitating, chronic pain caused by myriad disorders and injuries.

    Epilepsy. Marijuana is used as an adjunctive medicine to prevent epileptic seizures. Some patients find that they can reduce dosage of other seizure-control medications while using cannabis.

    Glaucoma. Marijuana can reduce intraocular pressure, alleviating pain and slowing (and sometimes stopping) the progress of the condition.

    Multiple Sclerosis. Marijuana limits the muscle pain and spasticity caused by the disease, and relieves tremor and unsteady gait.

    Muscle Spasm and Spasticity. Medical marijuana has been clinically shown to be effective in relieving these.

    Migraine Headaches. Marijuana not only relieves pain, but also inhibits the release of serotonin during attacks.

    Paraplegia and Quadriplegia. Many paraplegics and quadriplegics have discovered that cannabis not only relieves their pain better than opiates, but also suppresses their muscle twitches and tremors.

    Attending Heald Business College in downtown Oakland, CA in 1996, I overheard two young girls, about 19 or 20 years of age, discussing the upcoming elections.

    The first, a white girl, said she was going to vote in favor of the marijuana initiative, saying, “I think I should have marijuana.”

    The second girl, a black girl, said with amusement, “That’s for people with AIDS. They’re not gonna give it to you!”

    “They don’t have to give it to me,” replied the first girl. “I get it anyway.”

    In 1996, California voters passed a law to regulate medical marijuana within the state. In 2000, voters in California approved an initiative allowing people who are arrested for simple possession of drugs to go through a rehabilitation program rather than through the court process that would result in prison. Since the program began, most agree it has been very successful. It results in less recidivism and is considered cheaper than imprisonment.

    Tobacco kills about 430,700 each year. Alcohol and alcohol-related diseases and injuries kill about 110,000 per year. Secondhand tobacco smoke kills about 50,000 every year. Aspirin and other anti-inflammatory drugs kill 7,600 each year. Cocaine kills about 500 yearly alone, and another 2,500 in combination with another drug. Heroin kills about 400 yearly alone, and another 2,500 in combination with another drug. Adverse reactions to prescription drugs total 32,000 per year, while marijuana kills no one.

    A November 4, 2002 Time/CNN Poll found 80 percent of those polled felt marijuana should be legal only for medicinal purposes. 72 percent felt recreational users should get fines rather than jail time, which is essentially decriminalization. The complete legalization of marijuana was favored only by 34 percent of respondents, but this figure was twice as large as it was in 1986. Marijuana is safer than alcohol and tobacco, and our drug laws should reflect this reality.

    ****

    It’s obvious marijuana should be legal for medicinal purposes. But what about for recreational use?

    Nearly 75 percent of the drug war is directed solely at marijuana, which is safer than alcohol and/or tobacco.

    According to a 2003 Zogby poll, two of every five Americans said: “the government should treat marijuana the same way it treats alcohol: It should regulate it, control it, tax it, and only make it illegal for children.”

    Close to one hundred million Americans, including over half of those between the ages of 18 and 50, have tried marijuana at least once. Military and police recruiters often have no alternative but to ignore past marijuana use by job seekers.

    In September 2010, Alice A. Huffman, President of the California State NAACP, called on voters “to regulate and decriminalize marijuana.

    “According to the Center on Juvenile and Criminal Justice, half of California’s marijuana possession arrestees were nonwhite in 1990 and 28% were under age twenty.

    “Last year, 62% were nonwhite and 42% were under age twenty. Marijuana possession arrests of youth of color rose from about 3,100 in 1990 to about 16,300 in 2008 — an arrest surge 300% greater than the rate of population growth in that group.

    “If one were to calculate the number of black juvenile and young adult men alone, arrested in 2008 for nonviolent marijuana felony violations – over 5, 600 (and, which includes cultivation of a single plant), the criminal justice cycle entry costs would exceed $1.3 billion annually.

    “It is painfully evident that the war on drugs is a terribly failed policy which has a cost that is too high for taxpayers, and our communities.

    “Let’s keep California on the right side of justice.”

    Downtown Oakland, CA is now known as “Oaksterdam” with its medical marijuana facilities!

    And polls now show a majority of Americans (58 percent) favoring an end to marijuana prohibition.

    “I don’t get angry when my mom smokes pot…”

    –Sublime, “What I Got”

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