In This Issue:
Study to Determine Generic Drug Equivalency
More than 70% of epilepsy medicine prescriptions are for generic
drugs. A new study will help ensure generic drugs have the same effectiveness
as their brand equivalents.
The Epilepsy Phenome/Genome Project
We need YOU to help solve the mysteries of epilepsy
Epilepsy Research Foundation Grant Supports ‘EpiPen’ for
Seizures
A new grant will help develop a new fast non-intrusive method to
stop seizures in an emergency.
EQUIGEN
Benchmark
Studies to Determine
Equivalence
of Generic Anti-Epilepsy Drugs
"Many people with epilepsy and their
physicians have important concerns about the safety of switching from brand to
generic antiepileptic drugs, or switching among different generic products,”
says Michael Privitera, M.D., a professor of neurology at the University of
Cincinnati.
Some anti-epilepsy
drugs (AEDs) carry brand names and have no generic (non-branded)
alternatives. But approximately 70% of
AED prescriptions are generic, which means that every day in the US, more than
one million people with epilepsy take a generic anti-epilepsy drug.
To study the equivalence of brand and
generic AEDs, the primary therapies used to reduce or prevent seizures, Dr.
Privitera has joined a model public-private partnership called Equigen.
The Equigen studies, Privitera explains, “will determine how much
variation there is among different generic antiepileptic products, through
rigorous testing in people with epilepsy.”
Under so-called FDA bioequivalence rules, the amount of
medication or rate of treatment delivered by one drug may differ from that
delivered by another drug that the FDA has deemed "equivalent.”
But current FDA
bioequivalence rules were adopted 30 years ago with no scientific validation. The Epilepsy Foundation, American Epilepsy
Society, and American Academy of Neurology suspect the bioequivalence rules may
allow too much variability across
formulations.
Credible evidence suggests
that in a significant number of people, this variability can mean the
difference between controlled epilepsy and breakthrough seizures or other
negative consequences. Over the years,
FDA officials have received dozens of reports about increases in seizures and
unexpected side effects occurring after generic switches, and many requests to start
appropriate studies.
With financial help
from the Epilepsy Foundation, The American Epilepsy Society, and the critical
support of private donors such as the Arlene & Arnold Goldstein Family Foundation
and the Robert W. Smith Charitable Gift Foundation, the FDA recently approved funding for two Equigen studies to explore the equivalence of generic AEDs.
A highly-qualified
Equigen research team will test study subjects’ blood to determine if switching people from
one bioequivalent drug to another causes risky swings in drug levels. Each study subject will receive either a single or
multiple AED dose, after which the rise and fall of drug levels in their blood
will be precisely mapped.
“We expect the study to be completed in about 18
months,” Privitera said.
The Epilepsy
Phenome/Genome Project (EPGP)
We
need YOU to help solve the mysteries of epilepsy: How do we effectively treat it? How do we ultimately cure it?
Participate
in the largest epilepsy research study ever designed to understand how genetics
influences epilepsy, using the greatest store of knowledge in all
medicine: the Human Genome.
EPGP
researchers are currently seeking study participants who
- Have
epilepsy AND either a brother, sister, parent or child who ALSO has it OR
- Have
seizures from:
- Infantile spasms
- Lennox-Gastaut Syndrome
- Perventricular heterotopia
- Whose
epilepsy has been clinically well-characterized
Investigators will also enroll people
who do not have the disorder—so-called “controls” used for comparison. Study
participation will require minimum
involvement, but have maximum impact.
Critical
questions
Even with many advancements
over the last 15 years, critical questions about epilepsy remain unanswered.
- Why
does epilepsy often affect several members of the same family?
- How
can we predict the most effective anti-seizure drugs to use?
- What
causes epilepsy?
- How
long will seizures last?
Combining powerful genetic research tools and
the vast encyclopedia of life known as the Human Genome, UC San Francisco
(UCSF) Epilepsy Center director Daniel
Lowenstein, M.D. wants to solve the seizure disorder’s most persistent
puzzles.
 “We want to identify
potential molecular targets that could be the basis of much more specific and
effective treatments for patients who have epilepsy, and the prevention of
epilepsy in those at risk,” explains Lowenstein, who is also a professor and
vice chairman of the UCSF Department of Neurology.
Involvement
and impact
Involvement in the study does not
require an overwhelming commitment. Study
participants can expect to provide:
- About 2-4 hours of your time
- A blood sample and interviews
- Participants do NOT have to go to an EPGP research
center
- Participants receive compensation
Details about each patient’s disorder—type
of seizures, electroencephalogram and imaging study results, and effects of
treatment—will be collected and archived at UCSF.
All
clinical information and DNA samples will be de-identified so it cannot be traced to a specific
individual.
Participants
and partners
Still in its early
stages, EPGP is progressing remarkably through the work of both participants and partners.
Funding and additional
staff from the National Institutes of Neurological Disorders and Stroke (NINDS) assists
EPGP researchers at 27 clinical centers and affiliates in the U.S., Australia,
and Argentina.
With help from the
Epilepsy Foundation, the EPGP team now includes more than 200 clinicians,
scientists, nurses, study coordinators, site administrators, informatics
experts, database engineers, and advisory board members.
“I can’t emphasize how important it
is for the Epilepsy Foundation to have assisted us in our success thus far,”
Lowenstein says. “We would not be here
without their help. We will continue to
call on the Foundation as we head toward the final stretch of our goal. Thank you Epilepsy Foundation!”
To learn more about
the EPGP study and participate, please contact:
Email:
info@epgp.org
Or
call toll-free: 1-888-279-EPGP
On the Internet at www.epgp.org
Epilepsy
Research Foundation Grant Supports
Fast, Painless Auto-injection to Calm Breakthrough
Seizures
 Despite its
name, the EpiPen™ has nothing to do with epilepsy. It’s a fast, painless way to inject
epinephrine for severe allergic reactions that’s considered a real revolution
in emergency medicine.
Now, Steven Prestrelski,
M.D., co-founder and chief scientific officer of Xeris Pharmaceuticals, Inc.
has received an Epilepsy Research Foundation grant to develop a similar,
patented approach to help patients with seizures. Prestrelski
is designing a simple, pain-free way to inject
valium (diazepam) in multiple sites including the shoulder and abdomen—not just
the thigh muscle—that also eliminates the
need for rectal administration.
The low volume (10 to 100
micro-liters), subcutaneous auto-injection should take two seconds or less,
making it emergency ready for breakthrough seizures. The new formulation is also ultra-concentrated
and will not need to be reconstituted, saving time during medical emergencies.
With over 20 years of product
development experience, Prestrelski has ten patents for drug formulation and delivery. Here’s a quick
comparison of his method to current protocols:
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