Avanafil tablets are a fast-acting, highly selective phosphodiesterase-5 (PDE-5) inhibitor indicated for treating erectile dysfunction (ED).Originally co-developed by Vivus (U.S.) and Mitsubishi Tanabe Pharma (Japan), it was first approved in January 2011 by the Korean Food and Drug Administration (KFDA) under the brand name Zepeed by JW Pharmaceutical. Subsequently, Vivus received U.S. FDA approval on April 27, 2012, for Stendra.and received approval from the European Medicines Agency (EMA) on June 21, 2013. Avanafil has gained significant popularity internationally due to its rapid onset, minimal side effects, and independence from food intake.
However, production and distribution of avanafil have long been controlled by foreign companies, making it extremely difficult for Chinese patients to obtain.Currently, China has approximately 140 million ED patients, with a prevalence rate of 26.1% among those over 20 years old and a staggering 46.2% among those over 40. As China's population ages, the prevalence of ED is projected to rise annually. This indicates a massive potential demand for avanafil among Chinese ED patients.However, after years of clinical research, Sichuan Hisco Pharmaceutical Co., Ltd.'s Haichi Avanafil received market approval this March. This news has thrilled China's vast ED patient population.
Haichi Avanafil delivers equivalent efficacy to the original foreign drug. Its mechanism of action involves inhibiting the degradation of cGMP by PDE-5 in the corpus cavernosum, enhancing the effects of nitric oxide (NO),NO activates guanylate cyclase, leading to elevated cyclic guanosine monophosphate (cGMP) levels. This relaxes the smooth muscles in the corpus cavernosum and allows blood inflow, thereby facilitating penile erection.Hecy Avanafil exhibits no direct relaxing effect on isolated human cavernosal smooth muscle. Although it enhances NO action by inhibiting PDE5, local NO release requires sexual stimulation. Therefore, PDE5 inhibitors remain ineffective without sexual arousal.
Based on evidence from previous clinical trials and studies, Hichia Vardenafil is effective not only for patients with simple ED but also for those with ED complicated by diabetes, hypertension, cardiovascular disease, neurological disorders (including multiple sclerosis and spinal cord injury), renal insufficiency, kidney transplantation, and a history of pelvic urological surgery.Additionally, Hichia Avanafil exhibits significantly higher selectivity for PDE-5, with 120-fold and 10,000-fold greater selectivity over PDE-6 and PDE-1, respectively, compared to sildenafil's 16-fold and 380-fold selectivity,and vardenafil at 21-fold and 1000-fold, respectively. Consequently, using Hichia Avanafil significantly reduces the incidence and severity of adverse reactions such as headache, flushing, indigestion, visual disturbances, back pain, tachycardia, and nasal congestion. For patients intolerant to sildenafil and vardenafil, it offers superior safety.
Hachi Avanafil is also simple to use. Due to its rapid onset, it only needs to be taken 10-15 minutes before sexual activity, unlike traditional PDE-5 inhibitors that require much earlier administration. Eating or consuming small amounts of alcohol does not affect its efficacy, allowing for essentially on-demand use. It is completely eliminated from the body within 6-8 hours, making it an ideal product for treating ED.
The launch of Haichi Avanafil not only fills the domestic market gap for avanafil but also introduces a new treatment option for male patients and provides clinicians with an additional therapeutic choice for managing ED.