Early Access Program

General information: 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. In some countries, no approval is needed. By May 2018 there have been over a hundred approvals and shippings to Switzerland, Germany, Austria, New Zealand, UK, Lebanon and the USA.

The treatment: Currently, we can offer a 14-day treatment x 300mg per day. 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.

Application Information: To apply for an Individual Patient treatment, please download the instructions here (.rtf format can be opened in word; also available as PDF here, or email us for a word version at earlyaccess@emeramed.com).

Selected Country Information

No approval by the regulatory authority needed for the physician to order the drug:

  • New Zealand
  • Lebanon – Ministry of Public Health has approved the import by physicians for individual patients.

Approval by the regulatory authority not required under certain circumstances:

  • Austria
  • Germany – the physician can send us an email at earlyaccess@emeramed.com and we will explain how this is handled.

Approval from regulatory authority required in most countries:

  • Switzerland – a filled in application document for SwissMedic is found here (.rtf format can be opened in word). The physician can apply or several treatments, for un-named patients.
  • United Kingdom – A system has been set up through a company that handles the application process to the MHRA; the physician can send us an email at earlyaccess@emeramed.com and we will explain how this is handled.
  • US  – The FDA has a complicated two step process to obtain an Individual Patient IND.
    1) FDA form 3926 found here or here is used. Instructions are found here. The physician will obtain necessary documents for the application from us by sending an email at earlyaccess@emeramed.com.
    2) After approval by FDA, an Institutional Review Board (IRB) is required to oversee the actual treatment. There is a free IRB described in this document (.rtf format can be opened in word).
  • Sweden
  • Denmark
  • Australia
  • Canada
  •         Most other countries.