Teva and Alcobra Report Positive Data for ADHD Drug
Teva and partner Alcobra have reported new positive data on a candidate drug for attention-deficit hyperactivity disorder (ADHD) and have announced that they are planning to advance it to a full Phase III trials programme next year.
The success of the Phase II trial of MG01CI, an extended release formulation of Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate), has prompted Teva to make an undisclosed equity investment in Alcobra and negotiate the right to acquire the company outright should MG01CI reach the market.
Metadoxine has been used as a treatment for acute alcohol intoxication and treatment of alcohol withdrawal syndrome for more than 30 years.
In the 120-patient study, MG01CI-treated individuals showed significant improvements on a variety of tests used to measure ADHD symptoms, and the trial met both primary and secondary efficacy endpoints. Overall, 44% of the MC01CI patients showed improvement of at least 40% on rating scales, compared to 25% of those on placebo.
No differences were recorded in adverse event rates between treated patients and those on placebo.
Dr. Yaron Daniely, Alcobra’s chief executive, commented that “these results confirm previous clinical experience indicating MG01CI may have a quick onset of activity with few side effects, distinguishing it from other non-stimulant ADHD treatments”.
That profile could make MG01CI a strong entrant into the $5 billion market for ADHD drugs, which has continued to show fairly strong growth in the last few quarters despite speculation that it is due a major slowdown. At the end of last year for example Decision Resources suggested that market would contract to around $4.1 billion in 2015.
Additional Phase II study results for MG01CI in ADHD are planned to be presented at international scientific meetings later this year.
The news provided a boost for Teva’s branded drug division yesterday, coming just after the start of a US court case to defend top-selling multiple sclerosis drug Copaxone (glatiramer acetate) from generic competition.