As the world knows, Pfizer’s (NYSE: PFE) popular erectile dysfunction drug Viagra® has had an interesting ride since its approval for sale in 1998. Along with its competitor Cialis®, which is also approved for ED treatment, Viagra has had numerous price increases, safety queries, and most recently, government action. Let’s take a quick look at how this amazing story played out.
From A Classy Tablet To An Erection Pill
Thanks to the combinative chemistry of a sildenafil molecule (a substance derived from the flower of the species _Sildenafil citrate_ ), Viagra was originally approved as a tablet for the treatment of erectile dysfunction. With few treatment options available to men suffering from this disorder, many turned to the relatively new drug to treat their condition. As a result, Viagra tablets became incredibly popular and were soon seen as a generic form of Cialis®.
Before long, however, Pfizer discovered that the drug had other, more beneficial effects – namely, the ability to raise blood pressure in patients with erectile dysfunction and diabetes. Concerned about the drug’s safety, the company voluntarily added a new line of warning statements to the label of the tablets, dubbing them as ‘Blood Pressure’ medications and instructing physicians and patients not to take them if they had high blood pressure or were already taking hypertensive therapy. Later in 1998, the Food and Drug Administration (FDA) also asked physicians and patients to exercise caution when taking Viagra, especially in children, the elderly, and those with cardiovascular disease.
The End of the Beginning
Things were looking pretty good for Pfizer up until 2009, when the company announced an ambitious new plan to develop a generic copy of Viagra. As part of the plan, Pfizer began a process of acquiring smaller, more innovative biotech companies that could help it develop new drugs with different strengths and mechanisms of action. The largest and most influential of these companies was American pharmaceutical firm Viagra maker, Pfizer Inc. After completing the acquisition and partnering with several other smaller biotech companies, Pfizer eventually launched a new drug in 2013 – Viagra eFlow®, an oral reuptake inhibitor that is essentially a modified and improved version of sildenafil. The oral reuptake inhibitor (tadalafil) portion of the drug acts in a different manner to sildenafil, but it is still under the overall control of Pfizer, suggesting that it is still based on a sildenafil structure.
Big Changes In Store
Since its release in 2013, Viagra eFlow® has received mostly positive feedback from physicians and patients, though there have been mixed opinions on whether the drug is a true improvement over Viagra or whether it is simply a matter of marketing to create demand. One of the biggest changes, however, is the pricing strategy employed by Pfizer and other pharmaceutical companies in the industry. As the owner of the patent for sildenafil, Pfizer is able to set the price of the medicine, ensuring that it stays relatively affordable for patients.
Government Action
Due to fears of increasing healthcare costs and growing dissatisfaction with the pharmaceutical industry, there has been a renewed emphasis on the development of generic alternatives to expensive patented medicines. To that end, in 2014 the federal government enacted the Affordable Care Act, or ‘Obamacare’. Among other things, the law included a provision allowing all Americans to purchase affordable and low-cost generic medications through Healthcare.gov, an online insurance marketplace jointly run by the federal government and private companies. In addition to requiring pharmaceutical companies to provide low-cost generic medications, the law also introduced the concept of biosimilars, or ‘follow-on’ medications. These are copies of existing biotech medicines that are biologically derived from living cells and have not been fully tested on humans yet – in theory, they offer similar benefits to those already on the market and are thus, more affordable. One of the first biosimilar medicines to receive FDA approval was an erectile dysfunction drug, Zarzeczepine (Zenobase®), in April 2018.
Continued Growth
After years of fairly stable sales, Viagra’s total revenue for 2018 was predicted to be around $18 billion by research firm MarketLine. Given the current climate of increased scrutiny on drug prices and innovation, that figure is likely to rise.
What About Safety?
All drugs have the potential to be dangerous when abused, but few medicines are as dangerous as opioids. Just this year alone, the opioid epidemic claimed over 174,000 lives in the United States. Although the link between ED medication and opioid addiction is still unproven, many physicians and patients are still concerned about the potential side effects of these drugs. In an effort to allay these fears, Pfizer and other pharmaceutical companies have developed a new approach to opioid prescribing for some patients. In July 2018, the company announced a clinical trial that it will be participating in to test a potential new treatment for opioid addiction. If the trial is successful, the company plans to submit a new drug application for the treatment by 2021. The idea behind the trial is to use a fentanyl patch to help patients wean off of stronger painkillers like morphine and oxycodone. Fentanyl is a potent synthetic opioid medicine that is 100 times more powerful than morphine and 30 times more potent than heroin. It is manufactured and distributed by the pharmaceutical company, H.J. Crown Inc. (Nasdaq: HCRI).