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Dear all,
Can we conduct a Felbamate (An Anti-epileptic) BE study in healthy
volunteers ?
What's the requirement for FDA and also in other Regulatory agencies?
Need your valuable suggestions
Habeeb
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I do not think Felbamate PK study in healthy volunteers is an option.
The black box warning for this drug allows to prescribe it to patients
whose epilepsy is so severe that "THE RISK OF APLASTIC ANEMIA IS DEEMED
ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE" and "THE RISK
OF LIVER FAILURE IS OUTWEIGHED BY THE POTENTIAL BENEFITS OF SEIZURE
CONTROL". Neither the exposure (or dose) -response nor duration of
treatment - response are known for these AEs. With this it is not
safe to
give any dose, even a couple of single doses to healthy volunteers.
Katya
--
Ekaterina Gibiansky
Director, PK/PD
Clinical Development
MedImmune, Inc.
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Hi Habib,
you can check regulatory recommendations (these are not requirements,
though) for Felbamate study from following document.
http://www.fda.gov/cder/guidance/bioequivalence/recommendations/
Felbamate%20tab%2020189%20RC12-06.pdf
Best regards,
Rhishi
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Hi Habib,
you can check regulatory recommendations (these are not requirements,
though) for Felbamate study from following document.
http://www.fda.gov/cder/guidance/bioequivalence/recommendations/
Felbamate%20tab%2020189%20RC12-06.pdf
Best regards,
Rhishi
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Habeeb,
FDA has provided individual bioequivalence product recommendations at
http://www.fda.gov/cder/guidance/bioequivalence/default.htm
BE studies for felbamate are recommended only in epilepetic patients.
You can find the guideline at
http://www.fda.gov/cder/Guidance/bioequivalence/recommendations/
Felbamate%20tab%2020189%20RC12-06.pdf
Ganesh
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Ekaterina's advice looks good.. There was a cause celebre in the UK
over 20
years ago where a medical student died of acute aplastic anaemia about 3
months after he participated in a short study of single doses, if I
remember
correctly. The media caused a great stir and tried to blame the drug
that
had no record of such effects like felbamate ...It was diazepam.
Andrew Sutton
--
Andrew Sutton, MBBS, MD(London), FFA
Guildford Clinical Pharmacology Ltd.
The Technology Centre, Occam Road
Guildford, Surrey, UK. GU2 7YG
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The following message was posted to: PharmPK
Response to 1: RE: Felbamate BE study
Katya, If this is not safe to give Felbamate for healthy patients,
how come
that the recommendations are only from 12/2006? Prior to that, it was
recommended to perform regular fast and fed single dose studies?
Do you think epileptic patients will participate in this type of BE?
TS
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The following message was posted to: PharmPK
Tzviel,
I do not work with generics, and do not deal with the Office of Generic
Drugs, so others may have a better answer. But as I understand the
initiative to have BE guidances for individual products is a pretty
recent FDA idea. It may be that this guidance appeared in response to a
request for such a study, or may be it was finally time when drugs
starting on letter F were first in the queue :-)
Katya
Ekaterina Gibiansky
Director, PK/PD
Clinical Development
MedImmune, Inc.
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