Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Namuscla®
Compound: mexiletine hydrochloride
Therapeutic area: Rare diseases - Neuromuscular diseases
- sodium channel inhibitor. Mexiletine reduces skeletal muscle hyperexcitability by blocking sodium channels.
Company: Lupin Europe (Germany)
Disease: symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders
- • On October 18, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Namuscla®,intended for the treatment of myotonia in adults with certain hereditary muscle disorders.
Namuscla® will be available as capsules (167 mg).
The benefits with Namuscla are its ability to reduce muscle stiffness and improve quality of life in patients with non-dystrophic myotonic disorders (sodium or chloride channelopathies). The most common side
effects are abdominal pain, vertigo and insomnia; arrhythmias and DRESS (drug reaction with
eosinophilia and systemic symptoms) may occur. It is proposed that Namuscla® be prescribed by physicians experienced in the treatment of non-dystrophic
- • On 7-9 October 2014 the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for mexiletine hydrochloride for treatment of myotonic disorders.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2014-11-19
Pediatric exclusivit _USA:
Pediatric exclusivity UE: