| Nasulin
is the patented intranasal insulin spray of CPEX which incorporates
CPE-215 as a permeation enhancer. Nasulin
is designed to address the need for an insulin product that more closely
resembles the body’s normal physiological response and provides
a more patient-friendly delivery method. These potential
benefits could reshape the insulin market. In general, drugs
delivered via the nasal cavity have the potential to be
readily absorbed across the highly vascularized nasal mucosa
and directly into the circulatory system, thereby avoiding
first-pass metabolism in the liver. When absorbed, the speed
of absorption affords a faster onset of action compared
to the most rapid-acting, injectable insulin formulations.
A series of studies have confirmed that Nasulin delivers
insulin quickly through the nasal mucosa, even more rapidly
than subcutaneous injection.
According the 2007 prevalence data released by the United
States Centers for Disease Control and Prevention, or CDC,
the most recent year for which data is available, approximately
24 million people in the United States, or 8% of the population,
suffer from diabetes. A study published by Diabetes Care
in 2006 projects that the number of diagnosed diabetics
in the U.S. could reach 48.3 million by 2050 due to an aging
population, rising obesity rates and poor health habits.
Prescription trends show a preference for combining rapid-acting
injections during mealtimes with a once daily basal insulin
injection. Due to the time-action profiles of the rapid-acting
mealtime injectable insulins, patients are at increased
risk for hypoglycemic events and for gaining weight. The
ultra-rapid time-action profile of Nasulin has the potential
to reduce the risk of hypoglycemic events and of weight
gain. In addition, because Nasulin delivers needle-free
insulin, it has the potential to improve the acceptability
of mealtime insulin among patients with diabetes and has
the potential to improve adherence to insulin treatment
regimens.
We believe an intranasal route of administration will
yield an ultra-rapid time action profile which could provide
better glucose control equivalent to meal time injectable
insulins but with the potential for less hyperglycemia and
weight gain. In addition, based on current data demonstrating
that Nasulin does not enter the deep lung, this needle-free
route of delivery potentially avoids the pulmonary disadvantages
of competitive candidates that use an inhalation route of
administration.
We are currently seeking to sell or out-license the Nasulin program. For more information,
please contact:
Lance Berman, M.D.
Senior Vice President and Chief Medical Officer
CPEX Pharmaceuticals, Inc.
2 Holland Way
Exeter, NH 03833
(603) 658-6100
lberman@cpexpharm.com
For additional information (abstracts, poster reprints
and published articles) relating to Nasulin,
CLICK HERE.
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