Mens Health Erection Articles

generishe levitra pillen Ohne Rezept Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc.
(NYSE: KG) announced today that they have delayed plans for the initiation
of Phase 3 clinical trials with bremelanotide, a first in class
melanocortin agonist drug candidate, for the treatment of male erectile
dysfunction (ED). The decision follows responses from representatives of
the U.S. Food and Drug Administration (FDA), which raised serious concerns
about the acceptable benefit/risk ratio to support the progression of the
proposed program into Phase 3 studies for ED.
After reviewing the data generated in the Phase 1 and 2 studies, the
FDA questioned the overall efficacy results and the clinical benefit of
this product in both the general and diabetic ED populations, and cited
blood pressure increases as its greatest safety concern. Though not
supportive of the proposed Phase 3 studies for ED with bremelanotide, the
FDA stated that it was amenable to proposals for a different drug
development pathway, such as for a second-line therapy in non-responders to
currently approved PDE-5 inhibitors.
"The safety of patients in our clinical program has always been our
number one priority and we will work closely with the FDA, King, and our
advisors to determine the next steps for the program," stated Carl Spana,
Ph.D., President and Chief Executive Officer of Palatin.
Palatin and King plan to review the FDA comments in the overall context
of the program in order to determine next steps related to the further
development of bremelanotide for the treatment of ED.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated
with increasing age, cardiovascular disease, hypertension, diabetes,
hyperlipidemia, and smoking. In addition, certain prescription drugs and
psychogenic issues may contribute to ED. It is estimated that some degree
of ED affects one half of all men over the age of 40 and that 150 million
men worldwide suffer from ED.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on
discovering and developing targeted, receptor-specific small molecule and
peptide therapeutics. Palatin’s internal research and development
capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling
product development. Palatin’s strategy is to develop products and then
form marketing collaborations with industry leaders in order to maximize
their commercial potential. To date, Palatin has entered into
collaborations with AstraZeneca, King Pharmaceuticals, and Tyco Healthcare
Mallinckrodt. For additional information regarding Palatin, please visit
Palatin Technologies’ website at
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions,
of novel branded prescription pharmaceutical products in attractive markets
and the strategic acquisition of branded products that can benefit from
focused promotion and marketing and product life-cycle management.
Palatin Technologies, Inc

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