dm+d

109141001

Medicine Compliance Aid Stability

genericActavis UK Ltd

Actavis UK Ltd
generic
Tablets f/c 50mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
No special precautions for storage
No special precautions for storage
26 October 2015

RilutekSanofi

Sanofi
Rilutek
Tablets f/c 50mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special precautions for storage
26 October 2015

Lactation Safety Information

For amyotrophic lateral sclerosis
Very limited published evidence of safety indicates low levels in breast milk
Monitor infant for adverse effects associated with adult use
3 August 2020

New Medicines

Amyotrophic lateral sclerosis (motor neurone disease) - oral film formulation

Information

New formulation
Profile
Not Known

Development and Regulatory status

None
Pre-registration (Filed)
None
Oct 21Currently pre-registration in EU [2].

Category

An inhibitor of glutamate processes. Glutamate plays a role for cell death in ALS. Presented in a film formulation taken twice daily that melts on the tongue.
MND is mostly a sporadic disease of middle and elderly life presenting in the sixth and seventh decades. The incidence is 2-4 per 100,000 per annum, with onset typically in the sixth and seventh decades. The male to female ratio is 2:1 [1]. Approximately 3,000 patients in the UK have ALS [2].
Amyotrophic lateral sclerosis (motor neurone disease) - oral film formulation
Oral

Trial or other data

Mar 21PI cross-over trial completes (NCT04819438) [3].
Jan 21PI cross-over trial to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek tablets and to evaluate their bioequivalence starts (NCT04819438). 54 adults will be recruited in Switzerland. Subjects will be treated with one orodispersible film containing 50mg of riluzole or 50mg Rilutek tablets in two out of the four study periods according to the randomisation sequence. In the film group, before each administration, subjects will drink 20 mL of still mineral water in order to wet their mouth. Afterwards, using gloves, the investigator or deputy will take the orodispersible film (32.0x22.0 mm) out of the provided pouch and place the product directly on the top surface (dorsal aspect) of the subjects tongue. In the Rilutek group, one film-coated tablet will be swallowed (without chewing) with 150 mL of still mineral water. Primary outcome is Cmax and AUC0-t; collection of these data is due to complete Mar 21 [3].