Last year was a banner year for erectile dysfunction (ED) drugs. Three new brands were launched and another four were approved in the United States. While the conversation around ED is certainly shifting to become more holistic and include other factors, such as stress, poor nutrition, and addiction, the fact is that medication is still dominating the ED treatment landscape in the United States.
Viagra, Cialis, and Levitra are all still considered first-line treatments for ED. But what happens when those drugs aren’t enough? Does the patient need to try something else? Should he even consider trying something other than the medications listed above?
To find out, we need look no further than the latest blockbuster drug to hit the market. Thanks to the introduction of Fliksr – a pill developed to treat both ED and asthma — we now have an alternative to Viagra, Cialis, and Levitra. Does Fliksr live up to the hype? Let’s take a look.
Key Facts About Fliksr
Fliksr is a blockbuster drug being hailed as a ‘game changer’ for patients with both ED and asthma. Developed by a team of pharmaceutical scientists led by Dr. John Lim, the drug is a combination of vardenafil and nebivolol. It is believed to be the first ED pill that treats both ED and asthma. However, although the drug was designed to be used for treating both conditions, it has been studied and approved only for use in men with asthma who have ED. In December 2019, the US Food and Drug Administration (FDA) approved Fliksr for use in this patient population.
The clinical trial that led to FDA approval was called the FLiksr Inhaled Aerosol Monotherapy (FLAGS) Trial. It was a randomized, double-blind, placebo-controlled trial that investigated the use of Fliksr in men with moderate to severe asthma. In this trial, patients were randomized to receive either Fliksr (n=115) or placebo (n=116) via a mist inhaler at the end of each pant pant. The primary endpoint of the trial was the comparison of the change in FEV1 after 4 weeks of treatment. Secondary endpoints compared the rates of responders, defined as those who demonstrated a four-fold improvement in FEV1 based on pre-treatment values; the occurrence of adverse events; and quality of life measures. (1)
How Does It Work?
When used in combination, nebivolol is known to block beta-adrenergic receptor sites, which decreases responsiveness to catecholamines (such as noradrenaline and adrenaline). This, in turn, can lead to decreased blood pressure and irritation of the respiratory system. In addition to beta-adrenergic blockade, nebivolol has also been shown to inhibit the enzyme phosphodiesterase type 5 (PDE-5), which is responsible for degrading cGMP, a key molecule that leads to the relaxation of smooth muscle tissue.
Inhibition of PDE-5 leads to an increase in the level of cGMP in blood vessels, allowing for a better and more sustainable level of relaxation. This coupled with beta-adrenergic blockade has been shown to improve the efficacy of erectile dysfunction drugs and other medications that treat pulmonary hypertension. (2)
The fact that Fliksr is a combination drug with both vardenafil and nebivolol may explain why it has been shown to have a more potent effect than either of its individual components in pre-clinical trials. Pre-clinical trials are conducted to determine whether or not a medication has the desired effect in humans before it is subjected to clinical trials. In these trials, scientists take samples of blood or other tissues and test the medication for the desired effect. Animal trials are often used because it is much more affordable and convenient to test a medication in animals before trying it in humans. (3)
What To Look Forward To
While many patients will be able to benefit from Fliksr, those who are asthmatic and have ED should look forward to improved quality of life once they try it. In combination with proper care and treatment of their asthma, Fliksr may be able to help them manage both conditions better than they have been able to since their symptoms first appeared. This is why, as noted by the FDA, ‘this new agent offers the potential for improved control of both asthma and erectile dysfunction’.
This is exciting news for patients with concomitant asthma and ED. With proper treatment, there is a chance that Fliksr can improve their quality of life. There are, however, a few things that they should note about this drug. First, Fliksr is an ED drug and will not necessarily treat their asthma. Second, due to its mechanism of action, Fliksr can cause vasodilation, which may lead to reduced blood pressure. This is why it is not recommended for those with low blood pressure or heart disease.
Third, like all ED drugs, Fliksr also has the potential to be addictive. The FDA has warned patients and healthcare providers about this potential for addiction and has urged them to be aware of the risks before initiating treatment with Fliksr. Due to the nature of its mechanism of action, it is also highly likely that Fliksr will become less effective over time, which has been observed with other ED medications. (4)
There are many patients who are still unable to benefit from the previously mentioned medications due to lack of effectiveness or the presence of adverse events. Does Fliksr live up to the hype? Does it offer hope to men who cannot benefit from existing treatments? Let’s take a look.