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A new erectile dysfunction drug candidate clears another hurdle in clinical testing. The drug, if eventually approved by the FDA, would help impotent men who don’t respond to treatment with PDE5 inhibitors alone.
Still undergoing clinical trials, a new erectile dysfunction drug code-named IPED2015 is showing promising results. The medication is designed to treat severe ED and may offer hope for impotent patients who don’t respond to the PDE5 inhibitors, which are the preferred treatment for ED caused by insufficient blood flow to the penis.
Unlike the PDE5 inhibitors that temporarily optimize blood flow to the male genitals, the new drug candidate focuses on brain chemistry and the neurotransmitters associated with sexual response.
Developed by Initiator Pharma
IPED2015 is the brainchild of Initiator Pharma, a pharmaceutical company based in Aarhus, Denmark. The company was formed as a spin-off from Sweden’s Saniona AB.
In mid-March 2020, Initiator announced “statistically significant and clinically relevant results on key efficacy endpoints” after Phase IIa proof of concept trials, which involved the administration of a single dose of the experimental drug.
How the Drug Works
Laboratory testing has shown that IPED2015 in-vitro inhibited the transporters for dopamine, noradrenaline, and serotonin, which are neurotransmitters that have been linked to sexual response.
The Phase IIa trials included 12 male patients with erectile dysfunction so severe that it did not respond to treatment with currently available medications.
The erectile response of patients to the experimental medication was evaluated using RigiScan, a device designed to gauge the quality of nocturnal penile erections. All patients responded well in terms of erectile response and the ability to maintain rigidity.
New Drug Is Safe to Use
Also evaluated during the Phase IIa trials were the novel drug’s safety and pharmacokinetic profiles. After the trials were concluded, John Connell, chief scientific officer of MAC Clinical Research, which oversaw the trials, issued the following statement:
“This well-executed study was able to demonstrate, under a single protocol, a favorable safety and tolerability profile . . . in healthy male volunteers, as well as showing positive effects on established markers of penile rigidity in a panel of patients with erectile dysfunction.”
Findings from Animal Testing
In earlier animal testing, the new ED drug candidate induced “erections in anesthetized rats by a central mechanism involving inhibition of dopamine reuptake followed by activation of dopamine D2 receptors.” And testing also showed that combination treatment with a PDE5-inhibiting drug-enhanced erection quality. Results from the animal trials were published in the July 2018 issue of The Journal of Sexual Medicine.
For men whose ED symptoms are satisfactorily treated with Viagra, Cialis, and other PDE5 inhibitors, ordering those drugs online from eDrugstore.com has a number of advantages. Prices at eDrugstore include not just the drugs themselves but a bundle of time- and money-saving services as well.
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