Early Access

The use of drugs under development can be approved by a regulatory authority on a Named Patient Use basis. This is also called Early Access, Expanded Access, Single Patient Use, Individual Patient IND, or Compassionate Use, depending on the country. The approval is based on whether the condition to be treated is serious enough, whether efficient and safe treatments currently exist, and whether the drug has shown relevant efficacy and safety. An application for the treatment of a condition may be more easily approved if efficacy studies have been performed targeting that condition. Under Named Patient Use the physician is responsible for the treatment, and, in general, only a licensed physician can apply to the regulatory authority. By early 2017, SwissMedic (Switzerland) and FDA (USA) had approved treatments.

Early Access Program – Treatment with Irminix®

Currently, we are allowed to offer a 14-day treatment x 300mg per day. The treatment length and dosing are limited by those used in the completed Phase 1 and Phase 2a clinical studies. We cannot determine whether this treatment will be sufficient to treat a particular patient. In clinical trials on mercury intoxicated gold miners, there were positive effects on those with low, moderate and high mercury levels, while there was no noticeable effect on individuals with extreme urine mercury levels over 100 µg/L. We believe that the latter group required higher doses and/or longer treatment.

Selected Country Information

No Approval Required – The following countries do not require for regulatory approval for a physician to use an unapproved medicine:

New Zealand

Approval Not Required In Some Cases:

Austria

Approval Required – The following countries require regulatory approval for a physician to use an unapproved medicine:

Various EU Countries

Sweden

Denmark

United Kingdom

Various Non-EU Countries

Australia

Canada

US

Application Information

If you are interested in participating in the Company’s Early Access Use Program for Irminix®, please complete the following document

 

Early Access Application

and forward it to us by email to EarlyAccess@EmeraMed.com for evaluation (this document is not an application to a regulatory authority, but an application to us for review).