Botox Approved by FDA for Chronic Migraine

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Botox Approved by FDA for Chronic Migraine

Following years of Botox^® (onabotulinum toxin A) being used off-label to treat Migraine, the FDA has now approved it for the treatment of Chronic Migraine, which is defined in the FDA approved prescribing information a Migraine 15 or more days per month with headache lasting four hours a day or longer.

Botox^® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. Botox^® has a unique, protected molecular structure that stabilizes the core toxin in Botox^® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, Botox^® neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three months depending on the individual patient.

For Migraine prevention, Botox is injected into or around muscles. The number of injections and injection sites may vary based on the doctor's experience and preference. The new prescribing information recommends up to 31 injections into seven specific head and neck sites per session. You can read more specific information in the Botox prescribing information.

When the FDA approval was announced, Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, stated,

"Chronic migraine is one of the most disabling forms of headache. Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available."¹

Comments from Migraine specialists:

I wanted to know what Migraine and headache experts thought about the FDA approval, so I contacted several of them to get comments to share with you (in alphabetical order):

Dr. Rob Cowan (Migraine specialist, Keeler Center for the Center of Headache)...

"I think this is great news for the headache community, particularly those of us who are very sensitive to the side effects of systemic medicines and those of us (both docs and patients) struggling with medication overuse headaches."⁴

Dr. Richard B. Lipton (Professor and Vice Chair, Director, Montefiore Headache Center, Albert Einstein College of Medicine)...

"Chronic migraine, characterized by headaches on 15 or more days per month, is the most disabling of the primary headache disorders. We have shown that, in comparison with episodic migraine, chronic migraine is more likely to disrupt quality of life and produces many more lost days of work, social and family activity. Until now, all treatments for chronic migraine were "off-label". That is, treatments approved for other conditions were used without regulatory approval.

The approval of Onabotulinum toxin A, is great news for migraine sufferers. This is the first medication to ever receive regulatory approval for the treatment of chronic migraine. This approval should improve awareness of chronic migraine, increase access to effective treatment and define a regulatory path for other companies to seek approval for additional treatments."⁵

Dr. Elizabeth Loder (Migraine specialist, Professor of Neurology at Harvard Medical School, and president-elect of the American Headache Society)...

"I think the approval is a good thing for patients. We now have a drug that is approved for patients with the most disabling form of migraine, who ordinarily have been systematically excluded from drug trials. It is nice to see a company tackle this problem. The benefits on average are modest, but focusing on the average results can be misleading. Some patients have quite substantial benefits from the drug, while others do not. That is true of most medicines. Another thing about this treatment is that it is generally well tolerated.

A reporter from CNN I talked with suggested the trial results were 'underwhelming.' I told him I don't look at things that way. It would be great to find a drug that's a cure, but the reality is that's not how medical progress usually works. First we find a treatment that helps a bit, and that enables us to understand more about the problem and how to tackle it. The next drug works a bit better, and so on. Progress is usually incremental and I think any increment is something to celebrate. For someone with very severe headaches, even a small amount of improvement can make a difference in their ability to function or the number of times they have to go to the emergency department."⁶

Dr. Alan Rapoport (Migraine and headache specialist and Professor of Neurology at the David Geffen School of Medicine at UCLA)...

"This approval is a long time coming. We had no drug approved for the treatment of Chronic Migraine before Botox was approved. Many patients with these frequent, disabling headaches respond to other forms of therapy. But when there is not good response to withdrawal of overused acute care medications, Behavioral Therapy techniques and good preventive medications, onabotulinumtoxinA (Botox) should be tried. When given by experts, it is safe and often effective in reducing the number of headache days per month. Hopefully Botox will now be better covered by medical insurance companies. I am glad to add this therapy to the short list of effective medications for Chronic Migraine and similar headaches."⁷

Dr. Fred D. Sheftell (founder and directory of the New England Center for Headache, past president of the American Headache Society and the World Headache Alliance, chairman of ACHE)...

"I'm delighted that Onabotulinum Toxin A has received approval as a therapy for the treatment of chronic migraine. It is historical in the sense that it is the first and only preventive medication for the treatment of this disorder that affects millions of the US population. It has and will benefit many in the years to come."⁸

Dr. Stephen D. Silberstein (director of the Jefferson Headache Center, originally worked with Dr. Richard Lipton to define chronic Migraine)...

"Migraine is a debilitating but under-recognized neurological condition. BOTOX(R), now approved by the FDA for Chronic Migraine patients, is the first and only FDA preventive treatment option to treat chronic Migraine."⁹

Dr. William B. Young (Migraine specialist at the Jefferson Headache Center, professor of neurology at Thomas Jefferson University)

"To all the nay sayers and evidence-based medicine purists who have been keeping my patients from getting much needed treatment: I TOLD YOU SO!

This is a huge opportunity for millions of persons with chronic migraine to get treatment.

It is probably safer with fewer adverse side effects than any other medicine for chronic migraine.

The issue has been that this medicine works for chronic but not for episodic migraine. This is a really important point for patients to understand, and it extremely important scientifically to understand why this is, and we don’t yet. It took us a long time to figure this out, first because we studied episodic migraine because this only was the only type of migraine study we knew how to do, and then getting the right trial methodology for studying chronic migraine took a while.

As this is now the ONLY FDA approved medication for chronic migraine, it will be interesting to see how the medical insurance companies respond to this situation, and how long it will take them to come around and cover this admittedly expensive treatment.

I would like to see patient groups and politicians bring pressure on the drug companies to make this treatment available to appropriate patients."¹⁰

Living Well With Migraine Disease & Headaches continues to be a top listed title in bookstores and online booksellers. For a description on the book or an Amazon link, click HERE. To read an excerpt from my book or other content, check our Supplemental Content Section.

Remember:

Optimal health care can be achieved
only when patients are educated
about their health and patients and
physicians work together as
treatment partners in an
atmosphere of mutual respect.

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Summary and Comments:

Since many doctors have been using Botox off-label for Migraine prevention, what patients will truly gain from the FDA approval remains to be seen. Certainly, the research that led to the approval was sorely needed. As Dr. Young commented, researchers learned how to study chronic Migraine (as opposed to episodic) while doing the Botox research. The approval of Botox is getting a great deal of publicity. Hopefully, that will bring the plight of chronic Migraineurs to the attention of both the medical community and the general public and help raise awareness of the disease and how difficult it can be to treat.

A huge benefit to patients will be if insurance companies now start covering the treatment. At this time, many insurance companies are denying payment, stating that treatment with Botox for the prevention of Migraine is "experimental." I suspect that a stronger reason is that those who make such decisions for insurance companies take only a short-term view, and object to the cost of treatment. It may well be anticipated that insurance companies will now look at the definition of chronic that is in the FDA approved prescribing information and continue to deny coverage for patients who fall anywhere outside the definition. That definition is:

"Migraine ≥15 [15 or more] days per month with headache lasting 4 hours a day or longer.)"

Patients considering Botox treatment for Migraine prevention would do well to maintain a Migraine diary to document the frequency and length of their Migraines.

If you're considering Botox for your Migraines, please keep in mind that not all doctors who administer it are trained to inject it for Migraine treatment. Be sure that your doctor is trained and experienced in administering Botox specifically for Migraine treatment.

You can read more about the use of Botox for Migraine in Intradermal Botox to Treat Pain Disorders.

____________
Resources:

¹ FDA News Release. "FDA approves Botox to treat chronic migraine." U.S. Food and Drug Administration. October 15, 2010.

² News Release. "FDA approves Botox for Migraine headaches." Associated Press. October 15, 2010.

³ Friden, Joyce. "FDA Okays Botox to Prevent Migraines."MedPage Today. October 15, 2010.

⁴ Interview: Teri Robert with Dr. Rob Cowan. October 17, 2010.

⁵ Interview: Teri Robert with Dr. Richard B. Lipton. October 18, 2010.

⁶ Interview: Teri Robert with Dr. Elizabeth Loder. October 17, 2010.

⁷ Interview: Teri Robert with Dr. Alan Rapoport. October 17, 2010.

⁸ Interview: Teri Robert with Dr. Fred Sheftell. October 18, 2010.

⁹ Interview: Teri Robert with Dr. Stephen D. Silberstein. October 17, 2010.

¹⁰ Interview: Teri Robert with Dr. William B. Young. October 18, 2010.

¹¹ News Release. "Botox® FDA Approved as Prophyoactic Treatment Option for Adult Chronic Migraine Sufferers." Irvine, California. Allergan. October 15, 2010.

¹² Botox prescribing information.

Medical review by John Claude Krusz, PhD, MD

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