Palatin Technologies Inc. (Nasdaq: PTN) announced that their experimental drug, bremelanotide, was successful in its Phase 3 trial. The drug is meant to boost the libido of pre-menopausal women distressed by the lack of sexual desire.
The company announced Tuesday the bremelanotide showed significant improvement in the participants of their study compared to the placebo group. The Phase 3 lasted 24 weeks and involved more than 1,200 women diagnosed with hypoactive sexual desire disorder (HSDD). Women receiving doses of bremelanotide experienced more levels of desire and less of distress during the trial.
Bremelanotide is a synthetic peptide analog that imitates a naturally occurring hormone in charge of sexual desire. Palatin stated that so far, no new safety issues were linked to the experimental drug and added that in general, bremelanotide was well tolerated. The only side effect that was identified was nausea, which was described generally mild.
The Reconnect Studies, Palatin study on bremelanotide, is in charged of the experimental drug trials and investigates the drug as an on-demand treatment for premenopausal women. The Reconnect Studies reported that they had met the pre-specified co-primary efficacy endpoints in both Phase 3 clinical trials.
The co-primary endpoints met by the study for the Phase 3 trials were the Female Sexual Function Index: Desire Domain (FSDI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO). The results were evaluated by an independent committee that used multiple anchors of patient assessment of benefit, consistent with the FDA and guidance documents, SmallCap Exclusive reported.
Bremelanotide was utilized in a single dose, which was self-administered by premenopausal women before a sexual encounter, Chief Medical Officer of Palatin Johna Lucas stated that the studies showed that the experimental drug proved to be beneficial for those patients that responded to the treatment.
Sheryl A. Kingsberg, Ph.D., Professor of the Reproductive Biology at Case Western Reserve University School of Medicine explained that hypoactive sexual desire disorder is the most common form of female sexual dysfunction. She added that the distress component of HSDD causes women to have an adverse impact on their images, relationships and quality of life inside and outside the bedroom. Luckily, bremelanotide has proven to reduce distress in its Phase 3 trials.
Bremelanotide is considered a ‘female Viagra,’ although it comes in a different presentation
Drugs trying to address libido in women are often called “female Viagra,” but Palatin’s drug is distinct from the blue pill. Bremelanotide has some similarities with Viagra. The dose has to be taken before sexual activity rather than every day. But the main difference is that Palatin’s experimental drug is not a pill, is a shot.
Palatin wants to seek U.S. approval for the drug and expects to file with regulators in the second half of 2017. If bremelanotide is approved, it will compete with Addyi, a controversial drug with concerning side effects.
Addyi is a Valeant Pharmaceuticals International product and was approved in August under intense pressure from patient advocacy groups. Despite their efforts, the pill has sold poorly, and its side effects might have something to do with that fact. The drug can cause fainting and extremely low blood pressure. It cannot be mixed with alcohol.
Palatin Technologies Inc. Reconnect Studies continue while the results are continuously monitored. All data could be released in the next few weeks to improve the drug’s chances to be approved in the market next year. It is believed that Palatin will disclose more information about its bremelanotide trials in future sexual medicine and women’s health conferences and even in peer-reviewed journal publications.
“We could not be more pleased with the bremelanotide Phase 3 co-primary endpoint results. Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis,” said Carl Spana, Ph.D., CEO, and President of Palatin Technologies.
Bremelanotide boosted not only premenopausal women’ libido but also Palatin’s shares
Palatin shares went down 7.06 percent on Tuesday to $0.483. But after-hours trading made them surged 57.25 percent to $0.760. The company has a market cap of $42.81 million at 25.93 million shares outstanding, and stock prices have been trading for a year-and-a-month range of $0.36 to $0.86.
The daily chart of Palatin Technologies Inc. shares shows that the price has increased significantly since September and has been almost constant for the first half of October. Stock prices have been between $0.5 and $0.7. The company’s plan to seek FDA approval to sell Bremelanotide in the second semester of 2017 could mean plenty of revenues for Palatin and therefore, higher share prices, says SmallCap Exclusive.
Palatin Technologies Inc. is a biopharmaceutical company that focuses on developing targeted receptor-specific peptide therapeutics to treat disease with significant unmet medical need and commercial potential.
Palatin’s programs are based on molecules that mimic the activity of the melanocortin and natriuretic peptide receptor systems and its primary product in clinical development is bremelanotide to treat premenopausal women with HSDD or little desire with associated distress.
Source: SmallCap Exclusive