The future looks bright for companies targeting attention-deficit hyperactivity disorder (ADHD) according to a new Research and Markets report, which predicts sales in the seven major markets (7MM) will steadily rise from $6.1 billion in 2014 to $13.9 billion in 2024.
Of note, the U.S. is expected to generate $13 billion or 95 percent of total sales, up from a 90 percent market share in 2014.
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Released Friday, the authors project an 8.5 percent compound annual growth rate (CAGR) over the next seven years, driven by increased awareness and a greater willingness to treat the condition with drugs, especially in the adult population.
Many top-selling formulations will lose patent exclusivity during that time, including Shire’s Adderall XR, Novartis’ Ritalin LA, Janssen Pharmaceuticals’ Concerta and Eli Lilly’s Strattera. Sales are expected to remain strong, however, as a steady stream of new ADHD drugs moves through the pipeline.
New patents and franchises will be born, but is it more of the same for patients?
Dextroamphetamine and methylphenidate continue to crop up in various delayed-release and extended-release forms.
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Ironshore, a wholly-owned subsidiary of Highland Therapeutics, submitted an NDA on Tuesday for its lead candidate, HLD200, a delayed-release and extended-release formulation of methylphenidate. An amphetamine version of the drug is expected to move into a pivotal Phase 3 trial this year. Both candidates use the company’s novel drug delivery system, DELEXIS.
Ironshore is pitching its value-add as greater stability in the mornings. Patients with ADHD would take the medication the night before, allowing the drug to smoothly take effect as the individual wakes in the morning. Less drama at the breakfast table for many families, but will patient outcomes change?
Shire is in the same position, awaiting an FDA ruling on its drug SHP465; a long-acting, triple-bead, mixed amphetamine salts formulation. With the novel packaging, the drug is designed to control symptoms over a 16-hour timespan, as opposed to the 12-hour window its predecessor offered.
The company first submitted its application for SHP465 as far back as 2006, but the FDA responded with an Approvable Letter requesting more data on safety and efficacy. In a statement, the company said it now anticipates a commercial launch for SHP465 in the second half of 2017.
Neos Therapeutics is working with the FDA to get new versions of both major ADHD stimulants approved, using its proprietary modified-release drug delivery platform. It has commercialized Adzenys XR-ODT, an amphetamine packaged as an extended-release orally disintegrating tablet for ADHD. The company is also awaiting an NDA ruling for its XR-ODT formulation of methylphenidate, and a liquid suspension formulation of amphetamine.
In April 2016, Tris Pharma launched Dyanavel XR, a once-daily liquid amphetamine. Five months earlier, Pfizer brought QuilliChew ER to the market, an extended release, chewable version of methylphenidate HCl.
For patients and their families, dosing is undoubtedly becoming more and more convenient. Adherence is a major issue identified in the report. But are there any significant treatment benefits to be had?
Based in Tel Aviv, Israel, Alcobra was one company developing a novel non-stimulant therapy, metadoxine. Unfortunately, the drug failed to reach its primary endpoint in a Phase 3 trial, causing its stocks to plummet 43 percent when the news broke in January.
Truly novel drug development is hard. As Supernus, a company testing an antidepressant and an antipsychotic as potential therapies for ADHD drug notes:
“Our focus on drugs with established mechanisms of action reduces the risks, costs and time typically associated with pharmaceutical development.”
Focusing on modifications to existing drugs too often makes sense.
Photo: Adam Angelides, Getty Images
