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Scottish Medicines Consortium approves Lupin's NaMuscla® (mexiletine) to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders (NDM)

Tue 8th December, 2020 9:00am
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Scottish Medicines Consortium approves NaMuscla® (mexiletine) to treat
symptomatic myotonia in adults with non-dystrophic myotonic disorders (NDM)

Slough, UK, 8 December 2020: Lupin welcomes the Scottish Medicines
Consortium’s (SMC) decision to approve the use of NaMuscla® (mexiletine)
for the treatment of symptomatic myotonia in adult patients with
non-dystrophic myotonic disorders (NDM) in Scotland.(1)

NaMuscla is the first licensed medicine to treat symptomatic myotonia in adult
patients with NDM(3), an ultra-rare genetic neuromuscular disorder in which
the sufferer's muscles are slow to relax after movement. These symptoms occur
intermittently and unexpectedly, often causing pain, muscle weakness, fatigue
and impairment of physical activities.(2)

 “We are delighted that NaMuscla has been approved via the SMC fast track
process and are pleased to offer a confidential patient access scheme to
ensure patients in Scotland can access the only licensed medicine for this
rare debilitating disease,” said Ben Ellis, Lupin UK General Manager.
“Scottish patients benefit from the SMC’s tailored approach to rare
disease medicine health technology assessments. Lupin is committed to ensuring
all eligible patients can access NaMuscla, irrespective of where they live in
the UK.”

The SMC’s approval applies only in the context of the agreed confidential
NHS Scotland Patient Access Scheme (PAS).

For further information or media enquiries please contact:

Consilium Strategic Communications 
Sukaina Virji / Lizzie Seeley 
Tel: +44 (0)7738 499212

About Non-Dystrophic Myotonias (NDM) 
Non-dystrophic myotonias (NDM) are a heterogenous group of rare neuromuscular
disorders caused by mutations within ion channels in the sarcolemma membrane
of skeletal muscles and affects 1 in 100,000 people.(2) Non-dystrophic
myotonias exhibit both sodium and chloride channelopathies which result in
altered membrane excitability. The major clinical manifestation of the
non-dystrophic myotonias is muscle stiffness as a consequence of the myotonia-
delayed muscle relaxation after voluntary contraction. Additional common
symptoms include pain, weakness and fatigue, and can affect different parts of
the body, such as legs, arms or facial muscles, more severely.(2)
Myotonia in NDM patients has an onset in childhood and persists across their
lifetime. Although not life limiting, patients with non-dystrophic myotonia
can experience significant lifetime morbidity due to stiffness and pain
related to myotonia. Patients may perceive that myotonia increases in severity
over time, impacting daily life. Myotonia is described by patients in a
variety of ways (stiffness, cramps, pain, difficulty releasing a fist, or
difficulty swallowing or eating) which can contribute to substantial delays in
diagnosis and treatment, leading to decreased patient quality-of-life and
often significant disability.(7)

About mexiletine
In randomized controlled trials (3-5) mexiletine has been shown to
significantly reduce myotonia compared to placebo in adult patients with NDM,
reducing skeletal muscle hyperexcitability through its use-dependent,
voltage-gated, sodium channel blocking actions which are independent of the
cause of channel function. This resulted in an improvement in patient
quality-of-life and other functional outcomes.The most commonly reported
adverse reactions in patients treated with mexiletine are abdominal pain
(12%), vertigo (8%) and insomnia (12%), demonstrating mexiletine has a good
safety profile.(3,6)

About Lupin Limited
Lupin is an innovation-led transnational pharmaceutical company headquartered
in Mumbai, India. The Company develops and commercializes a wide range of
branded and generic formulations, biotechnology products and APIs in over 100
markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin
America (LATAM), Europe and Middle East regions.

The Company supplies medicines in cardiovascular, anti-diabetic, and
respiratory segments and has significant presence in the anti-infective,
gastro-intestinal (GI), central nervous system (CNS) and women’s health
areas. Lupin is the 3rd largest pharmaceutical company in the U.S. by
prescriptions and 5th in India by global revenues. The Company invests 10.3 %
of its revenues on research and development.
Lupin has fifteen manufacturing sites, seven research centers, more than
20,000 professionals working globally.(8)

1. Scottish Medicines Consortium Final decision December 2020. 
Last accessed 7/12/2020
2. Matthews E, Fialho D, Tan SV, Venance SL, Cannon SC, Sternberg D, et al.
The non-dystrophic myotonias: molecular pathogenesis, diagnosis and treatment.
Brain 2010; 133 (Pt 1): 9–22.
3. Namuscla summary of product characteristics,  Last accesses Nov
4. Statland JM, Bundy BN, Wang Y, et al. Consortium for Clinical Investigation
of Neurologic Channelopathies. Mexiletine for symptoms and signs of myotonia
in nondystrophic myotonia: a randomized controlled trial. JAMA. 2012;
308(13):1357–1365. [PubMed: 23032552]
5. Stunnenberg B.C, Raaphorst J, Groenewoud al. Effect of mexiletine on
muscle stiffness in patients with nondystrophic myotonia evaluated using
aggregated N-of-1 trials. JAMA. 2018; 320: 2344-2353
6. Suetterlin  KJ, Bugiardini  E, Kaski  JP,  et al.  Long-term safety
and efficacy of mexiletine for patients with skeletal muscle
channelopathies.  JAMA Neurol. 2015;72(12):1531-1533.
7. Trivedi JR, Bundy B, Statland J, et al; CINCH Consortium. Non-dystrophic
myotonia: prospective study of objective and patient reported outcomes. Brain.
2013;136(pt 7):2189-2200. doi:10.1093/brain
LUPIN Limited Investor Report FY2020 (Accessed Online: 3rdJuly 2020)
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