Date: 2018-10-18
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
Action mechanism:
- 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
Latest news:
- • 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
myotonic disorders.
- • 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2014-11-19
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
