Evolving War of PDE5 Inhibitors part 2

In addition, studies on the non-responder group along with the oral erectile dysfunction treatment method were conducted. As a result, a low-dose long-term administration method was attempted for the non-responders of the initial PDE5-Is group as a daily dosing method rather than as needed. It was also caused by the inducing effect. Long-term inhibition of PDE5 by chronic administration of PDE5-Is increased the expression of PDE5 receptor and maintained high cGMP concentration. Based on this, it was administered for the purpose of preserving the cavernous smooth muscle in patients who were scheduled to undergo prostatectomy due to prostate cancer. Even after prostatectomy, patients who were administered PDE5-Is at an early stage showed superior erection recovery compared to the control group.

In addition, the same risk factors such as diabetes, hypertension, hyperlipidemia, and obesity act in erectile dysfunction, ischemic heart disease, and metabolic syndrome, which are emerging recently, and these are all associated with endothelial cell dysfunction. In patients with these risk factors, erectile dysfunction may appear prior to comorbidities. Therefore, long-term administration of PDE5-Is improves endothelial cell function, resulting in a therapeutic effect on comorbidities along with erectile dysfunction, which eventually leads to erectile dysfunction. can be prevented

Based on these theoretical grounds and various clinical papers on the effects, Cialis released 5mg/28T in 2009 with FDA approval for low-dose, daily use, and in 2009, the battle for oral erectile dysfunction drugs was turned into a second round. As it enters the market, the concept of treatment for erectile dysfunction and its market share will undergo a major change.

In particular, the low-dose daily dosing method started to be prescribed to many patients because of the low side effects and the fact that it is a natural erection and sexual life that can always result in an erection in response to sexual stimulation. With this paradigm change, domestic Zydena also participated in the second round by releasing 50mg/30T using the relatively long action time, and additionally released 75mg/30T with a slightly better effect.

New indications for PDE5-Is for urinary disorders other than erectile dysfunction include benign prostate syndrome and lower urinary tract symptoms (BPS/LUTS). This is through research on the relationship between erectile dysfunction and lower urinary tract symptoms (LUTS) 1) NOS/NO level decreased in the prostate and penile smooth muscle, 2) Autonomic hyperactivity effects on LUTS, prostate growth, and ED, 3) Pelvic ischemia as a mechanism for LUTS and ED, 4) Alternate pathway mechanism: The mechanism of Rho-kinase activity/Endothelin activity has been suggested. In fact, the International Prostate Symptom Score improved in Erectile Dysfunction patients using PDE5-Is, and it was also consistent with the International Erectile Function Index. 

In fact, in 2012, Cialis received permission for use for lower urinary tract indications, so it applied low-dose daily therapy to patients with prostatic hyperplasia/lower urinary tract symptoms other than erectile dysfunction in the urology department. The indications were realized to include prostate/lower urinary tract symptoms other than erectile dysfunction, which meant that the evolutionary war would unfold in a more complex manner in the future.

At the end of 2011, Bayer attempted to take another leap forward by releasing an orally disintegrating tablet of Levitra. In Korea, the third domestic release of Avanafil from Choongwae Pharmaceutical was expected to intensify the battle for erectile dysfunction drugs. With the prediction and anticipation of patent expiry, the development of the generic Viagra drug was completed, and the third round of chaos was prepared.

As the domestic Viagra patent expired in May 2012, domestic Viagra generic drugs in four formulations (tablets, films, granules, and chewable tablets) were launched competitively. All arms of the company show a relatively high market share. Meanwhile, SK Mirodenafil, which had been struggling since its release just before the release of a generic drug in Korea, released a film first with an emphasis on portability. Viagrael, a film type, was also released in 2013. Currently, domestic erectile dysfunction treatment, high-dose, low-dose daily therapy is prescribed according to the characteristics of the patient when necessary.

As 비아그라 정품 generic drugs were released in Korea, sales of original drugs decreased, so Bayer's Levitra withdrew from the domestic market, and market share was reorganized mainly with cheap domestic generic drugs. As the domestic substance patent of Cialis expired in 2015, about 160 domestic Cialis generic drugs were released. The advent of Cialis generics has had a far greater impact on the market than Viagra generics.

The 비아그라 정품 drug is cheaper than the original and is available in a variety of formulations. On the other hand, since Cialis is based on a low daily dose, it can be administered chronically for systemic diseases where smooth muscle relaxation effects may work. In fact, in 2008, Cialis received FDA approval for low-dose, daily dosing, and BPH/LUTS in 2009, allowing it to be applied to the treatment of diseases other than erectile dysfunction. With the attempt to use it, the development of combination drugs became competitive. In particular, Hanmi Pharmaceutical, a domestic pharmaceutical company, succeeded in developing Gugudipine, a combination of Gugu, a Cialis generic, and Amlodipine, a high blood pressure treatment, following the success of Palpal, a 비아그라 정품 drug. It succeeded in developing Gugutams, a combination drug of

Even now, a combination drug for the treatment of erectile dysfunction and premature ejaculation, and a combination drug for the treatment of erectile dysfunction with dutasteride, which reduces the size of the prostate, are under development. In addition, various oral erectile dysfunction generic drugs from domestic pharmaceutical companies are being exported worldwide, and the domestic pharmaceutical industry is implementing various value-added survival strategies amid fierce competition.