National Headache Foundation Shares New Info That Could Benefit America’s 45 Million Sufferers
Chicago, IL— January, 30 2008 More than 15 years ago, the Food and Drug Administration approved the first triptan, a drug specifically designed for the acute treatment of migraine, ushering in a new era of drug research and development for migraine and chronic headache sufferers. Not only did headache sufferers find that a new line of targeted medications was available to treat their headaches, but the pharmaceutical industry finally took note of a large population in need of more effective medications. “For many years, there was limited research on headache,” said Seymour Diamond, M.D., cofounder of the National Headache Foundation, “but the approval of the triptan drugs for the acute treatment of migraine opened up the industry to the realization that there was a financial market out there for drugs for the long-standing headache sufferer. It is now interested in looking for newer and better methods.”
Studies such as the American Migraine Prevalence and Prevention Study (AMPP), sponsored by the National Headache Foundation, have been revealing large numbers of migraine and chronic headache sufferers who are not getting adequate treatment or the relief they need.
Reasons for discontent with current medications include:
• Slow onset of action
• Migraine recurrence
• Side effects
• Residual disability after treatment.
The good news is that more than 20 pharmaceutical and biotech companies are currently researching or developing new drugs to address headache and migraine. The road to drug approval is difficult and full of risks; on average an experimental drug requires 10 to 15 years to travel from the lab to the pharmacy and only one in five drugs tested on humans is ultimately approved. Here’s a look at some anticipated headache products, including generic versions of existing drugs, medications undergoing clinical trials, and drugs that are being re-packaged into different modes of delivery:
• Generics–Oral and intranasal generic sumatriptan are expected to be available in 2008 and 2009, respectively, (Ranbaxy Pharmaceuticals, Inc, and NovaDel).
• Inhalation device–Uses heat to vaporize a drug into an odorless mist that passes through the lungs into the bloodstream. The hope is to provide relief within 60 seconds. The device is currently in clinical trials using prochlorperazine. (Staccato® from Alexza Molecular Delivery Corp.)
• Skin patch–The system uses a transdermal patch containing the drug and a small battery-powered electronic controller that precisely controls the rate and amount of drug released from the patch. A patch is currently in clinical trials using zolmitriptan. (Actyve® from Vyteris). A sumatriptan transdermal patch based on proprietary SmartRelief™ iontophoretic patch technology is in development. (NuPathe)
• Nasal powders–A powder form of dihydroergotamine is being studied. Currently administered as a nasal spray, the powder form may be easier to use and more rapidly absorbed. (DHE Nasal Powder from Britannia Pharmaceuticals in collaboration with Novartis Pharmaceuticals)
• Inhalation–An orally inhaled formulation of dihydroergotamine is in development. Absorbed in the lungs, this formulation may provide ease-of-use benefits as well as rapid onset. (MAP Pharmaceuticals)
• New drug combination–A combination of sumatriptan and naproxen sodium that provides faster, sustained pain relief compared to each individual medication is expected in 2008. (Trexima® from Pozen Inc. in conjunction with GlaxoSmithKline).
• Medications with new uses–Drugs that were previously used to treat other conditions such as epilepsy, depression and Alzheimer’s are now being studied for their potential impact on headaches and migraines. Medications involved in current clinical trials include;
Tripleptal®, an anticonvulsant; (Novartis), Aricept®, an Alzheimer’s drug (Eisai), and Neurontin®, an anticonvulsant (Pfizer)
• New FDA indications–Three existing triptan medications are seeking additional FDA approvals. Frovatriptan (Endo Pharmaceuticals) has submitted an application to the FDA for a menstrual migraine indication, while rizatriptan (Merck) and eletriptan (Pfizer) are undergoing clinical trials to produce data for an FDA menstrual migraine application. An opiod medication already utilized in the clinical setting to treat migraine, butorphanol nasal spray, is in Phase III studies towards gaining an FDA-approved migraine indication (Intranasal Therapeutics).An angiotensin II receptor antagonist, olmesartan (Benicar®), is seeking an FDA migraine prevention indication. This class of medications is already FDA approved, and widely prescribed, for hypertension. Clinical experience and several small studies suggest they may also prevent migraines.(Sankyo Pharma Inc.). Doxepin, a FDA-approved tricyclic antidepressant, is seeking an FDA migraine prevention indication. (Winston Laboratories)
• New compounds–E2007 is an oral compound in early development that blocks activity at the AMPA-type glutamate receptor. The FDA has already approved medications that work at glutamate receptors to treat Alzheimer’s disease, but new research suggests that actions at this receptor may reduce pain as well. (Eisai). A compound with a similar glutamate receptor-blocking mechanism of action is also in initial clinical trials, Tezampanel. (Eli Lilly). A novel oral agent, LY334370, has just entered development.(Eli Lilly in a joint venture with CoLucid Pharmaceuticals). This compound acts at 5-HT1F receptors, which are specific sites on nerve cells. Similar to the triptans, this compound may ultimately prove to be more efficacious and better tolerated. Another agent with 5-HT1D receptor activity only, PNU-142633F, is also undergoing research. (Pfizer) This drug too may offer advantages in comparison to the triptans.
• Buffered diclofenac–A New Drug Application has been submitted for a tablet containing potassium bicarbonate as a localized buffer, which enables the active ingredient, diclofenac (a non-steroidal anti-inflammatory) to enter the bloodstream rapidly, providing quicker onset of action (ProEthic Pharmaceuticals, Inc.).
• Carbon dioxide Inhaler–This inhaler sends pressurized carbon dioxide up one nostril and out the other. Carbon dioxide would not be inhaled; rather it would permeate nasal mucous membranes. (Capnia)
• Vanilloid antagonist–A vanilloid receptor-1 antagonist that inhibits Capsaicin, Acid, and Heat Mediated Activation is in early development, compound 705498. (GSK). Zucapsaicin, a vanilloid receptor agonist and neuronal calcium channel blocker, is in Phase III studies. (Winston Laboratories)
• AK receptor antagonis–This approach selectively blocks transmission of pain signals from receptors without constricting blood vessels. (TorreyPines Therapeutics)
• Calcitonin gene-related peptide (CGRP) receptor antagonist–MK-0974 significantly improved migraine pain at two hours and 24 hours versus placebo. Phase III trials are planned. (Merck & Co.) In a recent study, an injectable CGRP1 antagonist, Olcegephant (BIBN-4096), yielded a headache response in 66% of patients versus 27% of placebo patients. (Boehringer Ingelheim)
• Capsaicin nasal spray–Capsaicin is the ingredient in cayenne pepper that gives it its hot and spicy taste. It relieves pain by destroying a chemical that carries pain messages to the brain. (Winston Laboratories)
• Nitric oxide metabolism–In early development, #274150, selectively blocks iNOS, which is a compound necessary for nitric oxide (NO) production. NO production within nerve cells is believed to contribute to migraine pain. (GSK)
• Medical procedures–The patent foramen ovale (PFO) is a hole between the right and left atrial chambers of the heart, which usually closes shortly after birth, however, it remains open in approximately 25 percent of people Surgeons have begun closing PFOs in patients with intractable migraine, finding a decrease in migraine and cluster headaches. A number of companies are studying the potential connection between PFO closure and migraines and are developing better techniques for surgical closure. (Premere® from St. Jude Medical Center). A novel device to perform a percutaneous procedure utilizing radio frequency energy to induce “tissue welding” is in being researched in foreign countries. (Cierra)
• Medical devices–A number of companies are developing implantable neurostimulation devices for headache sufferers who have not responded to other treatments. These devises deliver electrical energy to targeted nerves, thereby disrupting these nerves’ pain signals. (Precision SCS System® from Boston Scientific, Genesis ® Neurostimulation System from Advanced Neuromodulation Systems, Medtronic Synergy ® IPG from Medtronic, Inc., Vagus Nerve Stimulation Therapy from Cyberonics)
“While these new treatment options have interesting potential, the reality is that some will prove to be effective while others won’t, and headache sufferers should continue to work closely with their healthcare providers to decide upon the most effective course of treatment,” said Diamond.
ABOUT THE NATIONAL HEADACHE FOUNDATION
The National Headache Foundation, founded in 1970, is a non-profit organization which exists to enhance the healthcare of headache sufferers. It is a source of help to sufferers’ families, physicians who treat headache sufferers, allied healthcare professionals and to the public. The NHF accomplishes its mission by providing educational and informational resources, supporting headache research and advocating for the understanding of headache as a legitimate neurobiological disease. For more information on headache causes and treatments, visit www.headaches.org or call 1-888-NHF-5552 (M-F. 9 a.m. to 5 p.m. CT).
Interviews with NHF Executive Director Suzanne Simons and/or a physician expert are available upon request.
For an electronic copy of this release, e-mail kfagan@voxmedica.com
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CONTACT:
Suzanne E. Simons
Executive Director
National Headache Foundation
(312) 274-2651
ssimons@headaches.org
Kellie Fagan
Vox Medica
(215) 238-8500, ext. 1142
kfagan@voxmedica.com
