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. 2021 Aug;114(8):377-380.
doi: 10.1177/0141076821994535. Epub 2021 Mar 24.

The US Food and Drug Administration's authorisation of Purdue's controlled-release methylphenidate for adult ADHD: comments on the regulatory practice

Kim Boesen  1 , Karsten Juhl Jørgensen  1 , Peter C Gøtzsche  2
Affiliations

The US Food and Drug Administration's authorisation of Purdue's controlled-release methylphenidate for adult ADHD: comments on the regulatory practice

Kim Boesen et al. J R Soc Med. 2021 Aug.
No abstract available

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Figures

Figure 1.
Figure 1.
Meta-analysis of investigator-rated ADHD symptoms. Meta-analysis (Fixed effects model, inverse variance) of the four groups as reported in the FDA Statistical Review (appendix 7, table A-9). To enable meta-analysis of four arms versus one common comparator, we split up the placebo group in 4 (69 participants in total; 17 participants in each comparison) and kept the placebo mean change and standard deviation.
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References

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    1. The Efficacy and Safety of PRC-063 in Adult ADHD Patients. Last updated 7 May 2020. See https://clinicaltrials.gov/ct2/show/ NCT02139124.

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