After more than a decade of limited advancements in treatment options, a new medication for attention-deficit/hyperactivity disorder (ADHD) is now available in Spain. This development offers hope for children and adolescents who haven’t responded adequately to commonly prescribed medications, a challenge that affects a significant portion of those diagnosed with the condition.
The new drug, dexamphetamine sulfate, is marketed under the name Tentin and is intended as part of a comprehensive treatment plan for children and teenagers between the ages of 6, and 17. It’s designed for those who haven’t experienced sufficient relief from symptoms with methylphenidate, currently available in Spain as Concerta or Rubifen. MEDICE Ibérica is responsible for the drug’s commercialization in the country.
A New Option for ADHD Treatment
According to Dr. Maitane Núñez, Medical Affairs Manager at MEDICE Ibérica, the availability of Tentin “was necessary,” particularly for patients with more complex clinical profiles. The approval of the medication is based on clinical data, including the 2021 ATTENTION study published in the Scandinavian Journal of Child and Adolescent Psychiatry and Psychology.
The ATTENTION study demonstrated “clear improvement in the severity of symptoms” in children who hadn’t responded to methylphenidate. Nearly eight out of ten participants, aged 6-17, experienced a positive clinical response. The drug’s rapid onset of action – within 30 minutes – and its safety profile also contributed to its approval.
Dexamphetamine sulfate isn’t intended to replace existing ADHD medications, but rather to address a gap in treatment. It will be used specifically when a patient’s response to methylphenidate is deemed “clinically inadequate.” Researchers observed “statistically significant” improvements in symptoms and a positive clinical response in the majority of patients who hadn’t benefited from previous treatments.
In addition to its effectiveness, the pharmaceutical company highlights several key features:
- Rapid onset of action: Effectiveness is seen in just over half an hour.
- Prolonged effect: Beneficial for academic and social functioning.
- Adequate safety profile: Supports its use as part of a broader therapeutic plan.
The goal of treatment extends beyond symptom control, focusing on improving overall functionality – an increasingly important aspect of ADHD care.
While new to the Spanish market, dexamphetamine has been used for years in countries including the United Kingdom, Canada, Germany, and other European nations. Dr. Maite Ferrin, a psychiatrist and head of the ADHD Unit at Haringey Infanto-Juvenile Service (North London NHS Partnership), emphasized that Here’s “very quality news for professionals and families.”
Dr. Ferrin explained that the medication is already included in several international clinical guidelines, including those from the European ADHD Guidelines Group, CADDRA (Canada), the German S3 guidelines, and NICE (United Kingdom). This prior experience “provides security and confidence” to Spanish clinicians, allowing them to utilize a well-established treatment option.
Dexamphetamine belongs to a class of compounds known for their stimulating effect on the central nervous system. It works by increasing the availability of dopamine and norepinephrine, two neurotransmitters closely linked to ADHD. These substances play a role in attention, behavior regulation, and responsiveness to environmental stimuli.
By improving this chemical balance, many patients experience greater control over impulsivity and more sustained attention. While not a new mechanism in medicine, it’s a tool that, when applied correctly, can significantly improve the daily lives of those living with the disorder.
ADHD is one of the most common neurodevelopmental disorders diagnosed in childhood and adolescence, affecting an estimated 6.8% of children and teenagers in Spain. Despite its prevalence, Dr. Núñez noted that the recommended comprehensive approach – including psychotherapy, school support, and medication when necessary – isn’t consistently applied across the country. This disparity can lead to significant differences in patient outcomes and treatment response.
The introduction of dexamphetamine doesn’t resolve these systemic issues, but it does provide a much-needed resource. For many healthcare professionals, having an additional option after years without new treatments means they can better tailor treatments and address situations where existing tools have reached their limits.
