New Study Reveals Non-Prescription Migraine Treatment Safe and Effective

ORLANDO, Fla., May 7, 2018 /PRNewswire/ -- Questions regarding the safety of the popular migraine supplement Petadolex, manufactured by Linpharma, Inc., have been put to rest. Cephalalgia Reports, a neurological journal in association with the International Headache Society, has concluded the supplement to be safe after a comprehensive review published on May 2, 2018.

Petadolex, a non-prescription supplement taken to prevent migraine attacks, has come under scrutiny due to concerns it might cause liver damage. However, the new report finds Petadolex does not cause liver injury. The study is authored by neurologists and headache researchers Hans Diener, M.D. and Frederick Freitag, M.D. They, along with other pathology and liver specialists, carefully reviewed all documented cases of liver injury possibly related to Petadolex, including 10 serious case reports in total from the cumulative decades of use. After applying established Roussel Uclaf Causal Assessment Method (RUCAM) toxicity criterion, clinical data and an examination of available tissue biopsies, the researchers found the migraine supplement not responsible.

The report also reviewed clinical trial data, and reaffirmed that Petadolex is comparable in efficacy to commonly used prescription drugs for migraine prophylaxis and, "Is considered safe and an alternative to preventive prescription drugs with a positive benefit-risk ratio".

Petadolex, made in Germany, is manufactured with a patented process that extracts its active ingredient from the butterbur botanical. Butterbur plants can have naturally occurring alkaloids, which are potentially hepatotoxic. The process used when making Petadolex purifies the resulting supplement, eliminating any potentially toxic chemicals including hepatotoxic alkaloids. This fact has been documented in blinded testing by The National Center for Natural Products Research, and also in the report by Cephalalgia. All clinical trials testing the effectiveness of butterbur on reducing migraine frequency have used Petadolex, and none of them have resulted in serious adverse events.

Petadolex is subject to strict manufacturing and safety standards required by the German pharmaceutical regulatory agency, unlike U.S. supplement standards, which are less rigorous. According to Dr. Freitag, "This study confirms the safety of Petadolex concerning hepatic toxicity and reinforces its role as a top tier agent based upon efficacy and safety for migraine prevention."

For further information or to arrange an interview with Dr. Freitag, please contact Volker Gallichio at 407-466 6267.

SOURCE Linpharma, Inc.