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Evaluation of a new drug

Evaluation of a new drug. A new drug?. Cipramil: R- and S-citalopram Cipralex: S-citalopram. In-vitro results. Owens MJ et al.: S-citalopram was an approx. 30-fold more potent inhibitor of the serotonin transporter than R-citalopram

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Evaluation of a new drug

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  1. Evaluation of a new drug

  2. A new drug? Cipramil: R- and S-citalopram Cipralex: S-citalopram

  3. In-vitro results • Owens MJ et al.: • S-citalopram was an approx. 30-fold more potent inhibitor of the serotonin transporter than R-citalopram • S-citalopram was the most serotonin transporter selective compound when tested against all other marketed SSRI’s • Other tests: • Bioavailability, metabolism and elimination • Interconversion between R- and S-form • Activity of metabolites • Conclusion: • The majority of the therapeutic activity propably resides in the S-form

  4. Clinical effect Four clinical studies have been submitted: Wade et al.: Cipralex vs. placebo Cipralex sign. better than placebo Burke et al.: Cipralex vs. Cipramil Cipralex and Cipramil and placebo sign. better than placebo No difference between active treatments Montgomery et al.: Cipralex vs. Cipralex sign. better than Cipramil and placebo placebo. No difference Cipramil and placebo MD-02: Cipralex vs. Cipramil No difference between and placebo active treatments and placebo

  5. Clinical effect

  6. The advantage of pooling data... Gorman JM et al.2002:

  7. The advantage of pooling data... Tabel 2. LOCF values by visit for the major efficacy parameters: MADRS and CGI-I Study WeekPlaceboEscitalopram Citalopram MADRS 1 -3.8 -4.7* + -3.7 2 -6.6 -7.8 * -7.2 4 -9.4 -11.0* -10.2 6 -10.3 -13.0* + -12.0* 8 -11.2 -13.8* -13.1* MADRS-severe 1 -4.2 -5.5* + -4.3 2 -7.4 -9.0* -7.9 4 -10.4 -12.2* -11.3 6 -11.7 -14.7* + -12.8 8 -12.2 -16.2* + -14.3 CGI-I 1 3.5 3.3* 3.4 2 3.2 3.0* 3.1 4 2.9 2.6* 2.7* 6 2.8 2.4* 2.5* 8 2.7 2.1* 2.3* Gorman JM et al. 2002

  8. Choosing statistical analysis... Gorman JM et al., 2002:

  9. Choosing statistical analysis... Gorman JM et al., 2002:

  10. Conclusion - company • Cipralex provides an early ease of symptoms • Cipralex has a significantly better effect compared to Cipramil - also at severe depression • Cipralex is the most selective SSRI • Cipralex is well-tolerated with a safety-profile similar to that of Cipramil

  11. Conclusion - IRF It has not been shown that Cipralex has any clear cut advantages compared to Cipramil.

  12. Next morning...

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