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Pharmacokinetics of a Newly Identified Active Metabolite of Buspirone After Administration of Buspirone Over Its Therapeutic Dose Range

From Bristol-Myers Squibb Company, Princeton, New Jersey (Dr Dockens, Dr Salazar, Mr Fulmor, Dr Arnold, Dr Croop), and MDS Pharma Services, Lincoln, Nebraska (Ms Wehling). Dr Salazar is currently with Daiichi-Sankyo Pharma Development, Edison, New Jersey.

The objective of this study was to assess the pharmacokinetics of a newly identified active metabolite of buspirone, 6-hydroxybuspirone (6OHB), over the therapeutic dose range of buspirone. A 26-day, open-label, nonrandomized, single-sequence, dose-escalation study in normal healthy volunteers was conducted (N = 13). Subjects received escalating doses of buspirone with each dose administered for 5 days starting at a dose of 5 mg twice daily and increasing up to 30 mg twice daily. Plasma concentrations of 6OHB were approximately 40-fold greater than those of buspirone. 6OHB was rapidly formed following buspirone administration, and exposure increased proportionally with buspirone dose. Further research regarding the safety and efficacy of 6OHB itself is warranted.

Key Words: Buspirone • 6-hydroxybuspirone • 1-PP • anxiety • pharmacokinetics

Address for reprints: Randy C. Dockens, PhD, Bristol-Myers Squibb, Clinical Discovery, Route 206 & Province Line Road, Princeton, NJ 08543; e-mail: randy.dockens{at}bms.com.

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