U.S. FDA Approves Mydayis™ (mixed salts of single entity amphetamine product)

U.S. FDA Approves Mydayis™ (mixed salts of single entity amphetamine product)

Shire plc (LSE: SHP, NASDAQ: SHPG) announced on June 20, 2017 that the U.S. Food and Drug Administration (FDA) has approved Mydayis™ for treatment of ADHD.

Q: Indications for Mydayis™ use?

  • Patients 13 years and older with ADHD
  • Not indicatied for use in children 12 years and younger. 

Q: What is this US FDA approval based on? 

  • This is based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD.
  • In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents.
  • Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hours post-dose.

Q: What are the most common adverse reactions (incidence ≥5% and at a rate at least twice placebo)?

  • Insomnia
  • Decreased appetite, decreased weight
  • Dry mouth
  • Increased heart rate
  • Anxiety.

Q: What are the contraindications for Mydayis™ use?

  • Allergic to amphetamine or any of the ingredients in Mydayis. 
  • Taking, or have taken within the past 14 days monoamine oxidase inhibitor (MAOI).

Q: When will Mydayis™ be available in United States?

  • Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.

Note: Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence.

Source: Shire Press Release. Lexington, Mass., USA – June 20, 2017

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Dr. Harvinder Singh, M.D. (Admin)

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