29052-PorterJ32.ppt 06/14/22 09:01 AM /xx/fh/BF/ms/gb/SSK Multi- Media 1 Roger J. Porter, M.D. Roger J. Porter, M.D. Consultant Consultant Adjunct Professor of Pharmacology, USUHS Adjunct Professor of Pharmacology, USUHS Adjunct Professor of Neurology, Univ. of Pennsylvania Adjunct Professor of Neurology, Univ. of Pennsylvania Former Deputy Head, CR&D Former Deputy Head, CR&D , , Wyeth-Ayerst Research Wyeth-Ayerst Research Former Deputy Director, NINDS, NIH Former Deputy Director, NINDS, NIH Pipeline Presentation Pipeline Presentation ASENT: March 6, 2009 ASENT: March 6, 2009 RETIGABINE RETIGABINE
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Pipeline Presentation ASENT: March 6, 2009 RETIGABINE
Roger J. Porter, M.D. Consultant Adjunct Professor of Pharmacology, USUHS Adjunct Professor of Neurology, Univ. of Pennsylvania Former Deputy Head, CR&D , Wyeth-Ayerst Research Former Deputy Director, NINDS, NIH. Pipeline Presentation ASENT: March 6, 2009 RETIGABINE. - PowerPoint PPT Presentation
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29052-PorterJ32.ppt 04/22/23 06:06 AM /xx/fh/BF/ms/gb/SSK Multi-Media 1
Roger J. Porter, M.D.Roger J. Porter, M.D.ConsultantConsultant
Adjunct Professor of Pharmacology, USUHSAdjunct Professor of Pharmacology, USUHSAdjunct Professor of Neurology, Univ. of PennsylvaniaAdjunct Professor of Neurology, Univ. of Pennsylvania
Rundfeldt and Netzer, Rundfeldt and Netzer, Neuroscience Letters (Neuroscience Letters (17Mar2000) 282: 73-76.17Mar2000) 282: 73-76.
Retigabine shifts the KCNQ2/3 activation VRetigabine shifts the KCNQ2/3 activation V1/21/2 ~ -20 mV. ~ -20 mV.
29052-PorterJ32.ppt 04/22/23 06:06 AM /xx/fh/BF/ms/gb/SSK Multi-Media 7
Retigabine Phase I ResultsRetigabine Phase I ResultsDesired Pharmacologic EffectDesired Pharmacologic Effect
• Mechanism of action less well definedMechanism of action less well defined
• Cannot measure either seizure frequency Cannot measure either seizure frequency or a surrogate in normal volunteers.or a surrogate in normal volunteers.
• Only reliable measure of the desired Only reliable measure of the desired pharmacologic effect (efficacy) is RCCT.pharmacologic effect (efficacy) is RCCT.
• Phase I Phase I cannot contribute datacannot contribute data to support to support the desired pharmacologic effect (efficacy) the desired pharmacologic effect (efficacy) in this casein this case
29052-PorterJ32.ppt 04/22/23 06:06 AM /xx/fh/BF/ms/gb/SSK Multi-Media 8
Retigabine Phase I ResultsRetigabine Phase I ResultsPharmacokineticsPharmacokinetics
Pharmacokinetics well definedPharmacokinetics well defined•Rapid and almost complete absorptionRapid and almost complete absorption
•Dose proportionalDose proportional
•No self induction or inhibitionNo self induction or inhibition
•T 1/2 of 6-8 hoursT 1/2 of 6-8 hours
•Oral clearance of 0.7L/hr/kgOral clearance of 0.7L/hr/kg
•No significant drug interactionsNo significant drug interactions
29052-PorterJ32.ppt 04/22/23 06:06 AM /xx/fh/BF/ms/gb/SSK Multi-Media 9