How do you anger a man with a phrase?
A: “You can’t do it down there.
Erectile dysfunction (ED) is the medical term for “not working down there”. According to the National health and Wellness Survey, the overall prevalence of ED among men in China is 40.5%. Among them, oral medication is one of the most important ways to treat ED.
A market with such huge potential has given birth to a blue legend that has been circulating for more than two decades – Sildenafil, “Viagra”.
It is one of the most successfully marketed prescription drugs. Since its arrival in China, it has pushed the domestic market for anti-ED drugs up to 5 billion yuan; and in addition to curing the disease, it has even created a series of pop culture, simply because it is associated with passion and happiness ……
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Li Zongsheng’s “Recently more annoying” also has Viagra written in it
But few people know that an evenly matched rival to Sildenafil has been quietly born, and it is “long-acting Viagra” – Tadalafil.
Long-acting drug brings new treatment
Compared with sildenafil, the most distinctive feature of tadalafil is its long duration of action.
It is also a PDE5 inhibitor. Tadalafil and sildenafil have the same mechanism of action.
They selectively inhibit phosphodiesterase 5 (PDE5), which degrades cyclic guanosine monophosphate (cGMP) in the human penile corpus cavernosum, increasing the release of local endogenous nitric oxide (NO) from the corpus cavernosum in response to sexual stimulation, causing smooth muscle relaxation and increasing blood flow to the penile corpus cavernosum, thereby enhancing the natural response to sexual stimulation.
However, another study showed that the mean clearance of oral tadalafil in healthy subjects was 2.5 L/hr, with a mean half-life of 17.5 hours. In other words, the efficacy of tadalafil lasts 36 hours, which is 4 to 6 times that of sildenafil.
You can take one on Friday and be ready to take it on the weekend. When it was first introduced to the market, the main selling point of tadalafil was the “weekend pill”.
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Tadalafil is also known as yellow Viagra.
As research progressed, it was also discovered that 5mg of tadalafil was enough to maintain a hard erection for a full day. And after taking tadalafil 5mg daily for five days, patients were able to achieve prolonged steady-state blood levels.
This unique pharmacokinetic profile offers a new way of dosing for ED patients.
In the “on-demand” era of sildenafil, the rhythm of ED patients’ lives was completely dictated by the drug, which, although effective, was always a bit cumbersome to use.
Some ED patients themselves also suffer from multiple psychological problems such as low self-esteem and depression. “Every time I take a pill it seems to imply that I’m a failure. Clearly, this type of medication administration is not a friendly enough experience for patients.
But tadalafil came along to completely sever the link between sexuality and the drug.
In 2018, Chinese Men’s Journal published the Chinese Expert Consensus on “Tadalafil 5mg Once Daily for Erectile Dysfunction”, which officially provides clinicians with treatment guidelines for tadalafil 5mg once-daily therapy (5mg – OAD).
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Reference 2
With regular dosing of tadalafil, patients can experience the same ease of intake and output as normal. Not only does it make ED more manageable as a chronic disease, but it also reduces the psychological burden of ED patients.
According to surveys, patient satisfaction with the once-daily efficacy of tadalafil is as high as 93% and partner satisfaction is 87%.
With the word “long-acting”, Viagra has opened up a new era in ED treatment.
Few contraindications and high universality
In addition to the main advantage of “long-acting”, tadalafil also brings more surprises.
Clinical trial data showed that the average plasma sildenafil concentration in healthy male volunteers reached peak plasma concentration (Cmax) in 30 to 120 minutes (median 60 minutes) after a single oral dose of sildenafil 100mg.
However, such rapid results were obtained under fasting conditions. It was found that when sildenafil was taken with a high-fat diet, the absorption rate was significantly reduced, the time to peak (Tmax) was delayed by an average of 60 minutes, and the plasma peak concentration decreased by an average of 29%.
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The Viagra website reminds users to avoid high-fat diets
Unlike sildenafil, the 2018 Expert Consensus states in the area of dietary contraindications to tadalafil that
The use of tadalafil is largely unaffected by the consumption of food and alcohol.
Another advantage of tadalafil is that it is also effective in the treatment of ED in combination with medical conditions.
In the past, patients with severe ED associated with hypertension and diabetes have been difficult to treat clinically. Oral medications were often ineffective and only invasive therapies could be used.
However, a large randomized double-blind trial showed that 1112 patients with severe ED who took tadanafil had significantly improved erectile index.
Among the patients with diabetic ED, the erectile index improved from 0.9 to 7.4 for both type I and type II; 82.1% for those with hypertension and 86.4% for those with hyperlipidemia.
In a multicenter RCT, tadalafil 5mg-OAD treatment was compared with on-demand treatment to improve erectile function after radical prostatectomy (RP). At month 9 of treatment, erectile function scores were significantly higher in the tadalafil 5mg-OAD treatment group than in the 20mg on-demand treatment group and the control group.
This means that tadalafil 5mg-OAD is suitable for almost all ED patients who have no contraindications to the drug.
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The above patient categories are specifically recommended by expert consensus
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Last August, a new indication for tadalafil was approved for the first time in China for the treatment of ED in combination with benign prostatic hyperplasia (BPH).
Clinical statistics show that more than 70% of patients with BPH have combined erectile dysfunction. Professor Deng Chunhua, Director of the Department of Gynecology at the First Hospital of Sun Yat-sen University, commented: “At present, the only Viagra-like drug that can kill two birds with one stone is tadalafil.
The battle for the Viagra market has just begun
The ultra-long standby efficacy, more optimized treatment, and the diversity of “one drug, two kills” …… a series of advantages make sildenafil more and more courageous in the anti-ED drug market.
In 2014, Eli Lilly’s Cialis first surpassed Pfizer’s Viagra to take the top spot in the U.S. anti-ED drug market, and in 2018, its global sales reached $2.47 billion, surpassing Sildenafil across the board.
However, tadalafil, which has been sweeping the world, appears to be somewhat “unconvincing” in China.
According to China Pharmaceuticals’ financial report, the market valuation of tadalafil in China in 2019 was $800 million, which is less than half of the market valuation of sildenafil.
Why has tadalafil failed to replicate the success of overseas markets?
First, the long time perception shaped the position of sildenafil is difficult to shake.
Twenty years ago, Pfizer came to China with Viagra, and most of the domestic public’s scientific concept of ED was educated and shaped by Viagra. The little blue pill has even become more than just a drug, but a symbol of life.
In October this year, Pfizer also launched a “fast-acting Viagra” that claimed to work as fast as 12 minutes. Sildenafil continues to make a new voice in the market, and Viagra and ED have become firmly bound and engraved in people’s perceptions as if they were the tails of a coin.
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Data source: IQVIA
Secondly, price is a major advantage of sildenafil.
In 2014, the patent protection of Pfizer’s Viagra expired, generic pharmaceutical companies quickly entered the market, and the price of Sildenafil was lower and lower. The price of domestic Viagra “Jingo” is about 20 yuan a piece, 20% to 30% cheaper than the original research pharmaceutical companies.
Compared to Sildenafil’s popularity, the price reduction of Tadalafil appears to be late.
On January 7, 2019, tadalafil patent protection finally expired. As you can see from many e-commerce platforms, the price of 5mg tadalafil from the original drug company is currently about 18 yuan per tablet, while the price of the same size of the domestic generic drug is about 7 yuan per tablet.
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Price comparison between generic and originator drugs
The general manager of Jaspers China has commented that the competition in China’s Viagra market is not yet fierce enough, and this is a reflection of the fact that the market is still immature.
Data from Pharma Magic shows that the combined sales of PDE5 inhibitors in China exceeded 3.3 billion yuan in 2019, with a growth rate of more than 8%. Among them, sales of tadalafil tablets in China’s three major terminals of public hospitals at the city, county and township levels were about 135 million yuan, and sales in urban pharmacies were about 680 million yuan.
Although sildenafil is still the king at the retail end, with the price reduction and promotion of tadalafil, its market share in public healthcare institutions has now overtaken that of sildenafil.
The battle of the tigers in China’s anti-ED drug market may have just begun.
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