Xurta (lisdexamphetamine) is indicated in the deficit disorder with attention with or without hyperactivity (ADHD). Its particularity: it is an amphetamine. Classified as an amazing medication, Xurta has recently been available in pharmacies and is not (yet) reimbursed.
The arrival at Xurta’s pharmacy is doubly striking: it is a newly authorized drug in France in the treatment of attention deficit disorder with or without hyperactivity (ADHD), so far limited to methylphenidate, and it is the return of amphetamines in pharmacy. Indeed, unlike methylphenidate, xurta (lisdexampartamin dimésylate, dexamphetamine prodigogue) is a “real” amphetamine*.
Xurta obtained its AMM in France at the end of January 2025 and has been available in town for a few weeks, in the form of capsules dosed at 20 mg, 30 mg and 40 mg. It is very late compared to many European or North American countries that have lisdexampaper (and other amphetamine molecules) since the early 2010s, while France was shaken by the Mediator affair (Benfluorex, amphetamine derivative). “His arrival required pedagogy work, Dr. Hugo Prunier, psychiatrist in Lyon told AFP. The word “amphetamine” is scary in France, with prejudices shared both by caregivers and patients. »» Until then, lisdexamphetamine was only offered in compassionate access to the hospital. Xurta has an AMM, but it is not yet reimbursed (indicative purchase price for pharmacists: 52.90 euros).
Dispensation
In practice, Xurta is indicated in the overall management of ADHD in children aged 6 and over when the response to previous treatment with methylphenidate is considered clinically insufficient, and in adults with preexisting ADHD symptoms. Classified as amazing, he responds to strict dispensation rules:
– Annual initial prescription reserved for certain specialists (neurology, pediatrics, psychiatry);
– limited limited to 4 weeks;
– prescription on secure prescription;
– Not restricted renewal.
According to the RCP, the decision to prescribe Xurta must take into account: the patient’s profile, the potential for abuse, misuse or diversion and clinical response to any previous drug treatment for the treatment of ADHD. Its amphetamine nature forces the prescriber to follow a check-list points to check, before initiating treatment and during treatment monitoring. In particular, it must assess the cardiovascular state with measurement of blood pressure and heart rate, or the appearance or worsening of psychiatric disorders. He must also verify the absence of contraindication: hypersensitivity known to sympathomimetic amines, to lisdexample dimample or to one of the excipients, treatment concomitant by monoamine-oxidase inhibitors (MAOO) or use of an MAO in the previous 14 days (risk of hypertensive crisis), hyperthyroidism or hyperthyroidism or hyperthyroidism) Thyrotoxicosis, states of agitation, symptomatic cardiovascular disease, arteriosclerosis at an advanced stage, moderate to severe, glaucoma. During treatment, special attention is also paid to monitoring size (in children), weight and appetite as well as the risk of abuse, misuse and dependence.
The initial dose is 30 mg once a day in the morning during or outside the meals. The capsule can be swallowed entirely or open and its complete content mixed with a semi-liquid food (yogurt), or with water or orange juice. If necessary, the prescriber can start treatment at a dose of 20 mg once a day in the morning. The dose can be increased by levels of 10 or 20 mg at intervals of about a week. The recommended maximum dose is 70 mg/day. According to the results of clinical studies, the effects of the molecule are maintained for 13 hours in children and for 14 hours in adults (compared to 4 to 12 hours depending on the different specialties based on LP methylphenidate).
In case of forgetting, the dose is postponed the next day. Taking medication in the afternoon should be avoided due to the risk of insomnia.
HAS evaluation in progress
Xurta is being evaluated with the High Authority for Health (HAS). He was also on the agenda of the technical commission of July 16, to rule on his request for registration on the list of refundable drugs. “The allocation and therefore the opinion relating to the medical service rendered (SMR) and the improvement of the rendered medical service (ASMR) will be published in the coming weeks”confirm the Has.
*Methylphenidate is a psychostimulant whose chemical structure is related to that of amphetamine but it is neither an amphetamine nor an amphetamine derivative. Indeed, methylphenidate does not release dopamine newly synthesized in synaptic slit unlike amphetamine (HAS).
