Dear Patient or Physician: Before emailing questions, please send us the basic patient information in the word document found here: Early-Access-Application & Prescription – 21 Oct 2018 and it will be easier to help you and we will reduce administration time. (New Zealand physicians should use Early-Access Application & Prescription – 19 Nov 2018) and it will be easier to help you and we will reduce administration time.
General information: Drugs under development can be approved for use by a regulatory authority on an Individual Patient Use basis. This is also called Expanded Access, Named Patient Use, 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 are existing or lacking, and whether the drug has shown relevant efficacy and safety. The physician is responsible for the treatment. In most countries, only a licensed physician can apply to the regulatory authority. To date, we have experience with approvals and shipping to Switzerland, Germany, Austria, New Zealand, Lebanon and the USA. Most US patients and physicians finds the FDA process too complicated and costly and instead go to another country where the process is simpler.
The treatment: Currently, we can offer a 14-day treatment x 300mg per day. The treatment length and dosing are determined by the length of the Phase 1 and 2a clinical studies that have been performed. If this is enough depends on the individual patient – some require several treatments, typically with 28 days in between. There is no charge for the drug, but a flat fee of €600 ($750) for insurance-Shipping-Administration per two-week-treatment.
Selected Country Information
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
Doctors must fill out this early access form specifically for 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 – The Austrian form must be an urgently needed for the treatment of specific patient to avert a life-threatening or chronically debilitating situation and that successful treatment with licensed or available medicinal products cannot be achieved based on the scientific state of the art.
Approval from regulatory authority required in most countries:
- Switzerland – a filled in application document for SwissMedic is found here in German and here in French. The physician can apply for several treatments, for un-named patients.
- Germany – the physician can send us an email at firstname.lastname@example.org for info.
- United Kingdom – A system has been set up through a company that handles the application to the MHRA be for 1-25 un-named patients; the physician can send us an email at email@example.com for info.
- 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 firstname.lastname@example.org.
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).
- Most other countries.