Overview
On 15 March 2018, the Committee for Orphan Medicinal Products (COMP) adopted a negative opinion on the orphan designation application for melatonin for the treatment of non-traumatic subarachnoid haemorrhage. A negative decision was issued by the European Commission on 16 April 2018
The sponsor applied for orphan designation on the basis of the seriousness and the rarity of the condition, as well as an assumption of potential benefit over currently available methods of treatment.
The negative opinion was based on the following reason:
- the sponsor has not provided sufficient evidence to show that melatonin might be of significant benefit for patients with non-traumatic subarachnoid haemorrhage, compared with the authorised medicine nimodipine. The laboratory models used to assess significant benefit of the medicine did not adequately represent the condition.
Requests for designation as an orphan medicinal product are made for investigational products. Absence of orphan designation does not preclude the development of this product, including its use in clinical trials. A marketing authorisation can still be obtained if quality, safety and efficacy are demonstrated.
Key facts
| Active substance |
melatonin
|
| Intended use |
Treatment of non-traumatic subarachnoid haemorrhage
|
| Orphan designation status |
Negative
|
| EU designation number |
-
|
| Date of refusal of designation |
15/03/2018
|
| Sponsor |
Therapicon Srl
Via dei Grimani 10 20144 Milan Italy Tel. +39 02 433 042 Fax +39 02 481 952 24 E-mail: therapic@therapicon.com |
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
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: