Irminix® Early Access Program
The use of drugs under development can be approved by a regulatory authority on a Individual Patient Use basis. This is also called Expanded Access, Named Patient Use, Compassionate Use, or Specials, depending on the country. An approval from a regulatory authority is based on whether the condition to be treated is serious enough, whether efficient and safe treatments are existing or lacking, and whether the drug has shown relevant efficacy and safety. In general, only a licensed physician can apply to the regulatory authority. Early Access is ONLY available in New Zealand and Lebanon. Emeramed has discontinued our early access program in most of the world to focus our efforts on bringing Irminix® to market as soon as possible.
EmeraMed wants to cooperate with all researchers who are interest in utilizing this compound in human research at their own expense. The FDA regulations on human experiments with an investigative new drug (IND) require that the study must first be approved by the FDA and the investigators must have an Institutional Review Board (IRB) to protect the experimental subjects, and a data collection plan in place before the FDA will allow Irminix® to be shipped to the investigators. The USA FDA provides forms 1571-1572 and instructions. We do not charge researchers for Irminix® but we have to charge for our costs.
Veterinary applications and animal researchers should Contact: [email protected] regarding proposed study or therapeutic investigations. Bulk API (actual pharmaceutical ingredient NBMI) is available in 100 g containers and cost $2000.
Irminix®: The Treatment
Currently, we can offer a 14-day treatment x 300mg per day of Irminix®. The treatment length and dosing are limited by the clinical studies that have been performed. If this is enough for the individual patient or not, we cannot answer, as it depends on the indication (disease) to be treated, and the nature and severity of the disease of the individual patient. Additionally, Irminix® has not been approved for pediatric use.
No approval by the regulatory authority needed for the physician to order the drug:
- New Zealand – MedSafe allows the importation of Irminix® by authorized prescribers under Section 25 of the New Zealand Medicines Act 1981
- Lebanon – Ministry of Public Health has approved the import by physicians for individual patients.
Discover The Future of Health
We are committed to improving health by way of our unique metal chelator and antioxidant, Irminix®