Refusal of orphan designation for the treatment of painful HIV-associated neuropathy

Tramadol hydrochloride

Table of contents


On, 5 April 2006 the Committee for Orphan Medicinal Products (COMP) adopted a negative opinion on orphan designation of tramadol hydrochloride for the treatment of painful HIV-associated neuropathy of condition. A negative decision was issued by the European Commission on 21 September 2006.

The sponsor applied for orphan designation on the basis of the chronically debilitating nature and the rarity of the condition, as well as an assumption of potential benefit despite currently available methods of treatment.

The negative opinion is based on the following elements:

  • for the purpose of designation as orphan medicinal product, justification has not been provided for limiting the condition to “painful HIV-associated neuropathy”. Thus the proposed condition was not considered as a valid subset of the broader condition “peripheral neuropathy”;
  • the sponsor has not provided data to establish that peripheral neuropathy (hereinafter referred to as 'the condition') affects not more than 5 in 10,000 persons in the Community at the time the application was made*;
  • although satisfactory methods of treatment of “peripheral neuropathic pain” have been authorised in the Community, no sufficient justification has been provided that tramadol hydrochloride may be of significant benefit over current satisfactory treatments.

Requests for designation as orphan medicinal products are made for investigational products. Absence of orphan designation does not preclude the development of this product, in particular through clinical trials, and subsequently the possibility of obtaining a marketing authorisation if quality, safety and efficacy are demonstrated.

* Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed based on data from the European Union (EU 25), Norway, Iceland and Lichtenstein. This represents a population of 459,700,000 (Eurostat 2004). This estimate is based on available information and calculations presented by the sponsor at the time of the application.

Key facts

Active substance
Tramadol hydrochloride
Intended use
Treatment of painful HIV-associated neuropathy
Orphan designation status
EU designation number
Date of refusal of designation
TheraQuest Ltd
27 Heathdene Road
London SW16 3NZ
United Kingdom
Telephone: +44 208 765 15 75
Telefax: +44 1954 267 416

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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