FAQs - Lipigesic

Sublingual (under the tongue) administration is a delivery method that allows substances to be absorbed directly into the blood vessels and lymphatics of the mouth. These allow the medication to be absorbed rapidly.

Sublingual delivery methods bypass the digestive system. Medication that is taken orally travel through the digestive system and are carried to the liver where a high percentage of the effectiveness of the active medication ingredients is often destroyed.

Subligual delivery of medication has been found clinically useful for cardiovascular drugs, steroids, and some barbiturates and enzymes.

Start with one dose, five minutes later you may use a second dose. If you do not feel relief after 30 minutes, take another dose or two as needed or as directed by your health care provider.

LipiGesic-M works best if taken at the onset of a migraine, though it can be used at any point. Most users have reported excellent results even when the headache is well underway.

PuraMed BioScience^®, Inc., (PMBS: OTCBB) announces that the reanalysis of the clinical trial results of its homeopathic formulation, LipiGesic^® M, found that the migraine medication has “robust efficacy.” These results were  featured in the February 2013 issue of Headache: The Journal of Head and Face Pain, the official journal of the American Headache Society^®.

The article, Sublingual Feverfew/Ginger (LipiGesic M) Reanalysis of Data (attributed to Roger Cady, MD; Richard Lipton, MD; Daniel Serrano, PhD; and Rebecca Browning, BS) quoted Dr. Serrano, who provided the reanalysis as saying, “In conclusion, irrespective of design-type employed, the efficacy of sublingual feverfew/ginger (LipiGesic M) appears robust…”

The original double-blind, placebo-controlled clinical trial for LipiGesic M, completed in 2010 and published in the July 2011 issue of Headache: The Journal of Head and Face Pain, concluded that 64 percent of patients who used LipiGesic M found relief.

“This reanalysis not only confirms LipiGesic M is a highly effective, over-the-counter medication for the treatment of acute migraine pain,” said Russell Mitchell, chairman and CEO of PuraMed BioScience. “It also shows that if our study had included a larger patient population, LipiGesic M would have demonstrated a stronger efficacy across all measurement points.”

In a preceding article published in Drugs in 2012, Ryan Cady, Candace Shade, and Roger Cady, MD, describe LipiGesic M as an “excellent first-line therapy.” The article “Advances in Drug Development for Acute Migraine” goes on to cite LipiGesic M’s lower cost, its OTC availability, its unlikelihood to cause rebound headache, and its compatibility with other treatment options as advantages in acute migraine treatment.

“We have provided a safe, highly effective, OTC solution to migraine pain that performs as well as, if not better than prescription medications without the high cost, drowsiness, or the need for a doctor’s visit,” said Mitchell. “We are looking forward to the findings of the children’s study that was recently concluded to compare results across all age groups.”

LipiGesic^®M is distributed nationally in Walgreens and CVS/pharmacy stores.

It is important to hold LipiGesic-M’s gel under the tongue for at least 60 seconds before swallowing to allow maximum absorption into the blood stream. Because of its sublingual delivery method, LipiGesic-M is absorbed into the blood stream quickly. You can expect relief in minutes.

Feverfew is an herb that has been used for centuries to relieve many ailments including stomach aches, toothaches, psoriasis, allergies, problems with menstruation and labor during childbirth to name a few.

Commonly known as feverfew, bachelor’s buttons and featherfew, this member of the ragweed and chrysanthemum family, this herb has been shown to be powerfully effective in the treatment of migraine pain and associated symptoms.

Feverfew’s dried leaves have been formulated into pills and capsules; the fresh leaves have even been chewed to obtain this herb’s medicinal benefits.

Historically, pill and capsule formulations of feverfew have not been shown to be especially effective. It seems that our ancestors had the right idea when they would chew the fresh feverfew leaves. This allowed the active ingredients in the feverfew leaves to penetrate the soft tissues under the tongue and absorb directly into the blood stream providing relief from many ailments.

Today, if you have a migraine, you don’t have to chew leaves.

LipiGesic® M makes it easy to obtain the potency of this herb in its patent-pending homeopathic preparation of feverfew and ginger.

When you feel a migraine coming on, simply squeeze the contents of a pre-measured unit dose dispenser under your tongue and hold the gel in place for 60 seconds. Follow the initial dose with a second dose five minutes later.

Many users say LipiGesic M stops migraine fast; some feel relief in a matter of minutes.

According to the National Center for Complementary and Alternative Medicine, a department of the National Institutes for Health, feverfew has no serious side effects. However, because of its ability to contract the uterus, it should not be taken by pregnant women, nor should people with allergies to ragweed or chrysanthemums take the medication.

You can find LipiGesic® M at your local Walgreens and CVS/pharmacy stores. Now you can download our introductory $5 coupon.

Feverfew 3x (Pyrethrum Parthenium) the main active ingredient in LipGesic M is an herb that has been recognized for centuries as having a beneficial effect on migraine, menstrual and other headaches.

Feverfew 3x acts to inhibit over-aggregation of platelets*, though to be part of the migraine cascade. In a migraine attack, these platelets release serotonin, which causes abnormal blood vessel tone, and can result in both their dilation and construction (both of which are believed to contribute to migraine attacks). Inflammatory substances are released locally, which then contribute to the severity of the attack. Feverfew 3x blocks the production of these inflammatory substances**, without constricting the blood vessels, and short-circuits the migraine cascade.

Ginger 2X has also been shown to be anti-inflammatory, specifically suppressing the expression of several mediators felt crucial in migraine pathogenesis. In studies, Ginger 2X is shown to suppress the pro-inflammatory compounds (cytokines and chemokines) produced by synoviocytes (cells comprising the synovial lining of the joints), chrondrocytes (cells comprising joint cartilage) and leukocytes (immune cells)

*Groenewegen, WA J Pharm Pharmacol. 1990 Aug;42(8):553-7

**Kwok, BH Chem Biol. 2001 Aug;8(8):759-66

If you purchased LipiGesic M on our website and are not satisfied after trying your free box for 30-days, call Customer Service at 877-852-5295 for your return authorization number (REN). You will need to return two (2) unopened boxes of LipiGesic M to the address that the customer service representative will provide. No return products will be accepted without an REN. You will receive a refund for the total purchase price less shipping and handling.

If you purchased LipiGesic M at a retail store, please refer to the store’s return policy.

LipiGesic M is classified as an over-the-counter (OTC) drug and complies with all FDA regulations and guidelines for homeopathic drugs in the United States. It is manufactured according to Good Manufacturing Practices (GMP) and the manufacturer must have an OTC Drug License.

OTC products are heavily regulated. The Federal Trade Commission (FTC) regulates advertising and product claims.

No, LipiGesic M is not habit forming and it does not cause rebound headaches, which are characterized as headaches that occur due to the repetitive or overuse of headache medication.

Homeopathic drugs are those whose active ingredients are listed in the “Homeopathic Pharmacopoeia of the United States (HPUS)” and which contain only concentrations of active ingredients allowed for therein.

New Survey Reveals Critical Demand for Fast Migraine Relief

Press release courtesy of the National Headache Foundation.

If an average day begins as a hectic race to get the kids off to school and get to work on time, imagine starting that day with a migraine.

For many of the nation’s estimated 30 million migraine sufferers whose lives are often turned upside down by their migraines, relief can’t come soon enough.

In a new survey released today by the National Headache Foundation (NHF), 3 in 4 migraine sufferers said their current medication doesn’t work fast enough to get them back to their life when a migraine strikes suddenly or upon waking. These findings are being released as part of National Headache Awareness Week, June 6-12, and the NHF’s 40th anniversary. The survey was supported by Zogenix, Inc. and Astellas Pharma US, Inc.

“Migraine knowledge and treatments have advanced exponentially over the last 40 years, but these new study findings are a reminder that we have only begun to scratch the surface of this complex, biological disease,” said Robert Dalton, executive director, NHF. “More education, along with awareness and adoption of the newest treatment options, is critical for migraine sufferers who are not experiencing fast relief from their current medications.”

Headache-related activities such as screenings and public education forums are being hosted around the country during National Headache Awareness Week to bring attention to the nationwide problem of headache and to encourage sufferers to recognize their headache patterns and seek help.

Key Survey Findings

In the national survey, 500 migraine sufferers were asked about their migraine attacks, treatment satisfaction and experiences, and desired prescription medication attributes:

• The majority of sufferers (54%) said their prescription oral migraine medication is not useful for every migraine attack, yet less than 20% use another prescribed medication when an oral tablet is not an option
• Nearly 1 in 4 who don’t use another prescription medication simply endure their headaches.

“It is critical that both physicians and patients communicate about the nature and impact of the migraines so they can choose the best treatment plan for them. Every migraine is not the same, so a single treatment approach may not work,” said Roger Cady, M.D., vice president of the NHF board of directors, and director of the Headache Care Center in Springfield, MO. “Fast-acting, non-oral treatment options are needed particularly for those who experience migraine attacks associated with sudden onset, waking, nausea or vomiting.”

Additional key findings from the survey show that:

• Sufferers Aren’t Satisfied and Highlight the Need for Speed in Migraine Relief: A majority of sufferers (51%) are dissatisfied overall with their current medication
• The most desired prescription medication attribute offered “the fastest relief possible regardless of form” (41%), followed by an “ability to use the medication and return to normal activities” (38%)
• One Treatment Doesn’t Fit All Migraine Attacks
• Rapid onset migraine was the most common type of attack, affecting 69% of respondents — 66% also experience migraines with nausea and/or vomiting
• Patient-Physician Dialogue isn’t Translating to Better Treatment
• Most sufferers (roughly 2/3) have told their doctor that their prescription oral treatment doesn’t work for all of their migraine attacks, yet only 1 in 4 say their doctor has told them they need more than one drug to manage their variable attacks. “I have a stressful job, aging parents to check on, and nine grandchildren whom I love dearly. I am always on the go and don’t have time for a migraine,” said Sandie Griffin, 55, of Ozark, MO. “Fortunately, my doctor recently prescribed a new medication that quickly relieves my pain, and after years of literally losing days at a time to one headache, I have finally been liberated.”

The Enormous Toll of Migraine

Migraine is a debilitating neurological condition characterized by throbbing pain, usually located on one side of the head and often accompanied by nausea and sensitivity to light and sound. Women are three times as likely as men to experience migraine. Poorly managed migraine translates to a potentially huge impact on a patient’s quality of life — from missed or non-productive work days to lost family and personal time.

The direct and indirect costs associated with migraine are staggering: it is estimated that industry loses $31 billion per year due to absenteeism, lost productivity and medical expenses caused by migraine. Furthermore an estimated 157 million workdays are lost annually because of the pain and associated symptoms of migraine. The personal toll of migraine also is significant: in a recent study, nine out of 10 migraine sufferers reported they can’t “function normally” during days in which a migraine strikes, and nearly three in 10 required bed rest.

Helping People with Headache for 40 Years

June 2010 marks the National Headache Foundation’s 40th anniversary. Over the past four decades, the NHF has revolutionized the approach to understanding and treating headache. By advancing migraine education, funding research, and fueling new treatment development, the NHF has led the way in this complex area of medicine. Today, there is a better understanding of the causes behind headache, more comprehensive education for migraine sufferers, and a variety of powerful treatments to tackle this biological disease.

With dozens of public education campaigns, a comprehensive support group network, online learning modules and toolkits, and a toll-free hotline, the NHF has assisted millions of migraine sufferers seek education and treatment for their condition. The NHF has also played a central role promoting the education and research of migraine with physicians, allied healthcare professionals and health care policy decision makers. “As we celebrate our 40th anniversary, the National Headache Foundation remains steadfast in our commitment to improving the lives of people with migraine by promoting the advancement of headache education and treatment,” said Dalton.

About the National Headache Foundation

The NHF is a nonprofit organization that has pioneered the way headaches have been diagnosed and treated over the last 40 years. No other organization provides such comprehensive educational resources and tools to headache sufferers, their families, physicians who treat headache sufferers, allied healthcare professionals and to the public. The leaders of the organization are world-renowned experts in the field who have pulled together many easy-to-use tools and resources to help people better understand headaches and options for headache care. This information is available on the NHF website at www.headaches.org or by calling 1-888-NHF-5552 (M-F, 9 a.m. to 5 p.m. CT).

About the Survey

The National Migraine Treatment Survey was conducted on behalf of the National Headache Foundation via telephone in March 2010. It included a national sample of 500 clinically diagnosed migraine sufferers between the ages of 25 and 45. The survey was supported by Zogenix, Inc. and Astellas Pharma US, Inc.

About the Survey Sponsors

Zogenix, Inc., located in San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. Zogenix also plans to license their patented needle-free drug delivery system to other companies. For additional information on Zogenix please visit www.zogenix.com.

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of anti-infectives, cardiovascular, dermatology, immunology, neuroscience, and urology. For more information about Astellas Pharma US, Inc., please visit www.astellas.us.

Media: —— Robert Dalton / National Headache Foundation 312-274-2670 / rdalton@Headaches.org

Jackie Quintanilla / Edelman 323-202-1053 / jacqueline.quintanilla@edelman.comSOURCE National

Read or Download the NHF Critical Demand Migraine Relief PDF here

LipiGesic M is safe for people of all ages who suffer from migraine pain. However, women who are pregnant or breastfeeding should not use the product unless specifically directed to do so by a doctor. You will also want to consult your health care provider if headaches are a new condition for you, occur daily, or have sudden onset.

Also, do not use LipiGesic M if you have an allergy to any of the ingredients.