10 years later, Shire gains FDA approval for ADHD drug
pharmafile | June 21, 2017 | News story | Research and Development, Sales and Marketing | ADHD, Shire
Shire has revealed that the FDA has approved its long-acting and interestingly named ADHD drug, Mydayis. The approval comes more than 10 years from the first time that the drug was submitted to the FDA in 2006. After a series of set-backs, the company has now filed sufficient data for the approval of the drug.
Mydayis, until recently known as SHP 465, is able to control symptoms of those with ADHD for up to 16 hours. This is a four hour improvement on Shire’s Adderall XR, which lasts for 12 hours. This is where the dissimilarities end, as Mydayis is simply a reformulation of the previously mentioned drug but with a longer release of action.
The new drug is aimed at adults who would now have to take two doses of the Adderall XR to manage their symptoms through the full course of the day – the new formulation should mean that these individuals now only need to take one pill.
The approval was based on 16 clinical trials that were undertaken to prove the safety of the longer-lasting formulation. The trials enrolled 1,600 people, including adolescents, with the findings revealing that the medication boosted scores of the Permanent Product Measure of Performance, a standard measure of ADHD symptoms.
Andrew J. Cutler, Executive Vice President and CMO at Meridien Research and an investigator in the Mydayis clinical trials said: “Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings – often across home life, school or work, and in social settings. Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options. It’s rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD.”
The projected annual sales of the drug are between $300 and $500 by 2020.
Ben Hargreaves
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