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Nasulin is the patented intranasal insulin spray of CPEX which incorporates CPE-215 as a permeation facilitator that addresses 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. 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, 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. will 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.

Nasulin is currently in Phase 2 clinical trials and is being developed for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes. We believe an intranasal route of administration will yield an ultra-rapid time action profile which will reduce hyperglycemia with less risk of hypoglycemia and weight gain. In addition, this needle-free route of delivery avoids the potential pulmonary disadvantages of competitive candidates that use an inhalation route of administration. Our expectation is to finish key efficacy Phase 2 trials in patients with Type 2 diabetes in 2011 while simultaneously seeking a pharmaceutical partner to support Phase 3 clinical trials and product commercialization upon regulatory approval. While the terms of any future alliance will be determined through negotiation, we would look to license the product in return for upfront payments, milestones and royalties that reflect our research investment, innovation and potential market size.

For additional information (abstracts, poster reprints and published articles) relating to Nasulin, CLICK HERE.

 
The information posted is as of 10/02/2009 and, to our knowledge, was timely and accurate when posted. We are under no obligation to update or remove outdated information other than as required by applicable law or regulation.
 
 
 
MARCH 03, 2010
CPEX PHARMACEUTICALS REPORTS 2009 FOURTH-QUARTER AND YEAR-END FINANCIAL RESULTS
 
FEBRUARY 18, 2010
CPEX PHARMACEUTICALS ANNOUNCES ARCADIA OPPORTUNITY MASTER FUND WITHDRAWS PREVIOUSLY STATED INTENTION TO SUBMIT SHAREHOLDER PROPOSALS AND NOMINATE DIRECTOR SLATE AT 2010 ANNUAL MEETING

ARCADIA RETAINS INTENT TO NOMINATE ONE DIRECTOR

 
FEBRUARY 01, 2010
CPEX PHARMACEUTICALS ANNOUNCES APPOINTMENT OF NEW CHIEF SCIENTIFIC OFFICER
 

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CPEX PHARMACEUTICALS, INC.
2 HOLLAND WAY
EXETER NH 03833

TEL: 603.658.6100
FAX: 603.658.6101