Palatin Technologies Inc, a biopharmaceutical company, announced the presentation of positive safety and efficacy data from its Phase 2B "at home" study of PT-141 for male sexual dysfunction. Men with erectile dysfunction (ED) taking the intra-nasally administered investigational drug PT-141 reported consistently improved erectile function across all dosing levels.
The study results were presented on November 1st at the 8th annual leadership conference on sexual, cardiovascular and metabolic syndrome related therapies in Los Angeles, by Perry Molinoff, M.D., executive vice president of research & development for Palatin Technologies.
Carl Spana, Ph.D., president and CEO of Palatin Technologies stated, "We are pleased to have met our primary and secondary study endpoints. We achieved our objective of identifying doses of PT-141 that are safe, effective and well tolerated. Based on these positive results, we have established a specific range of doses that we will use to advance PT-141's development program toward a Phase 3 pivotal trial. PT-141's product profile, including quality of erections and time to onset, indicates that it has the potential to offer ED patients an attractive alternative to currently approved therapies."
"As a physician treating ED patients, I am encouraged by these results which show that PT-141 could treat a broad range of patients, including those with severe ED," said Dr. Christopher Steidle, M.D., study investigator and clinical associate professor of Urology at the Indiana University School of Medicine. "Some patients could tell the difference between PT-141 initiator properties and sildenafil facilitator properties and preferred the PT-141 experience due to their increased confidence and reduced anxiety about their sexual performance."
The placebo-controlled, randomized, double-blind, parallel group study enrolled 271 sildenafil-responsive men with mild/moderate and severe ED at 21 sites. Importantly, the trial included patients with co-morbidities such as diabetes, hypertension, hyperlipidemia, and smoking. Participants were confirmed by patient history to be responsive to sildenafil and had a baseline International Index of Erectile Function - Erectile Function domain (IIEF-EF) score of between six and twenty-one. The IIEF-EF is a standard sexual function questionnaire used by urologists, which includes questions on a man's ability to achieve and maintain an erection. To evaluate PT-141's effect versus placebo, researchers compared baseline scores with scores reported after treatment. Enrolled patients were randomized to either placebo, 5 mg, 10 mg, 15 mg or 20 mg of PT-141 for a one-month treatment period.
All doses of PT-141 demonstrated safety, importantly; there were no reports of hypotension or syncope at any PT-141 dose level. The 5mg and 10mg doses were well tolerated. The most common adverse events in these doses were mild to moderate in intensity and included bad aftertaste, facial flushing, nausea, post-nasal drip, fatigue and headache. Of the 271 patients randomized into the study, approximately 12 per cent discontinued due to adverse events. Discontinuations due to gastrointestinal adverse events were limited almost exclusively to patients taking the 15mg and 20mg doses. Patients who took multiple 15mg and 20mg doses of PT-141 tolerated the drug well.
A total of thirty patients in this Phase 2B study from five different trial locations who responded to PT-141 and were also sildenafil users were interviewed by an independent market research firm following the study to better understand their experience with PT-141. The research indicates that:
Approximately 70 per cent of patients considered PT-141 to be as or more effective than sildenafil; The quality of erection achieved with PT-141 is perceived to be comparable or superior to sildenafil in 83 per cent of patients; PT-141 has a longer duration of action and onset time was more rapid than sildenafil.