Poland approves world-first OTC switch of tadalafil

We continue with the theme of Rx-to-OTC switch this week with news from Poland, where the Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) has approved Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) as an OTC medicine, effective 1st February 2022. This will join Adamed’s sildenafil options MaxOn Active (25mg) and MaxOn Forte (50mg), which launched in May 2016 and April 2020, respectively. Tadalafil is claimed to get to work within 30 minutes for up to 36 hours, vs claims for sildenafil that it works within 30-60 minutes for up to five hours.

Poland was again one of the most active Rx-to-OTC switch markets in 2021, with only China ahead of it last year in terms of number of launched products reclassified from prescription to OTC status. Three of the six products launched post-switch in Poland in 2021 were erectile dysfunction treatments, including Hasco-Lek’s Mensil Max, Aflofarm’s Inventum Max and Polpharma’s Maxigra Max (all sildenafil 50mg). In addition, there were two digestive health switches – Teva’s antidiarrhoeal Gastrolit and Polpharma’s antacid Famotydyna Ranigast – and Polpharma’s cold sore treatment Heviran Comfort Max.

Source: Nicholas Hall’s CHC New Products Tracker

Nicholas Hall’s Touchpoints: Last week our lead story was the likely switch of HRT in the UK, which we singled out as a pioneer. The latest news this week is from Poland, another switch centre of excellence and where the ED treatment tadalafil will be available in a non-prescription version for the first time anywhere in the world. Tadalafil was launched as a prescription medicine under the trademark Cialis, and Sanofi later acquired the CHC rights from Lilly, but the switch application in the USA has been held up for many years by the FDA.

My colleague Maryna Marriott of the CHC Insight Europe team tells me: “Poland continues to lead the way in switch innovation. The tadalafil approval follows a number of sildenafil 25mg and 50mg switches, with the Polish ED category totalling US$27.7mn in MAT Q3 2021, according to DB6, an increase of 28.5% vs the year-ago period. Men’s health clearly remains high on the consumer health agenda, and it seems likely a number of other tadalafil switches will follow in Poland.”

Switch is an expensive process in the USA, which is why it is subdued there at present. On the other hand, there has been renewed switch activity in Europe and parts of Asia. The problem for the CHC industry has always been that the benefits given to US companies gaining switch status – the cost to the patient-as-consumer drops substantially and there is often three years marketing exclusivity, whereas the ingredient can no longer be prescribed for the same indication – are not available to marketers in the rest of the world. That leads to the curious situation of some switches being regulatory wins but commercial failures. Let’s hope that Adamed is blessed with decent sales for its latest innovation.

Find solutions for success in this competitive CHC landscape with Nicholas and the team in Athens on 4-6 May 2022 for our 32nd European CHC Conference & Action Workshop! Meet with peers and hear from industry experts, including sessions from Bayer, Teva, J&J and many others face-to-face! For more information, or to reserve your seat, please contact elizabeth.bernos@NicholasHall.com.

Male Contraceptive Clears Latest Hurdle

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Following recent trials for a hormone-based male contraceptive, another experimental new type of contraceptive, which blocks sperm flow with a gel, has been successful in monkey trials. Vasalgel creates a semi-permeable barrier which, once injected into the vas deferens, prevents sperm from crossing and causes them to be reabsorbed by the body.

The company behind the innovative creation says a two-year trial shows the gel works and is safe in primates. There will hopefully be enough evidence to begin tests in human males within a few years. If these are successful, regulatory approval will be requested to make the gel more extensively available.

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This would be the first new type of male contraceptive to hit the market in many decades. At the moment, men have two main options of contraceptive; to wear a condom to catch the sperm, or have a sterilising operation (vasectomy) to cut or seal the two tubes that carry sperm to the penis from where they are made in the testicles.

Vasalgel has the same end effect as vasectomy, but researchers plan to make the reversal easier and with a higher success rate, should a man later decide he wants to have children. The plans will be that another injection should dissolve the semi-permeable gel barrier, making sperm fertile once again. This worked in early tests in rabbits, but the researchers have yet to prove the same in monkeys and humans.

The non-profit company researching Vasalgel, the Parsemus Foundation, has used grants and fundraising to get this far. Researcher, Professor Pacey commented: “I would imagine there is a worldwide market for a new male contraceptive, but trials in humans and more long-term safety data are required before we will know if it is a success.”

Male Contraceptive Has Moderate Trial Success

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The next frontier of sexual liberation is close – the male contraceptive is almost here!

For decades now, scientists have been progressively working towards developing birth control for men, and the recent news that the injected male contraceptive is now just as effective as its female counterpart is groundbreaking.

In a trial of 320 men, aged between 18 and 45, researchers found that, over a one-year period, a new hormone-based injection was 96% effective in preventing pregnancy.

The hormones injected into the men on the trial were shown to dramatically lower their sperm count by “switching off” the male reproductive system.

The drugs did however cause some unpleasant side-effects, meaning that the trial had to be halted early. Of the 320 participants, 20 experienced mood swings, depression, muscle pain and acne. Despite this, 75% of the participants said they would be happy to take the male contraceptive on a regular basis.

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Richard Anderson, a professor of clinical reproductive science and author of the study, said: “If you’re comparing it to other reversible male methods, it’s far better than the condom and it puts it in the same ballpark as the pill.”

The male contraceptive is not the only new and innovative form of protection that is set to be on offer. The predominantly male condom is now available in female form. The disposable contraceptive device, which is marketed by The Female Health Company, is the only female condom approved by the US FDA and cleared by the World Health Organization.

The condom provides dual protection against unintended pregnancy and sexually transmitted infections, offering what it claims to be a thoroughly safe sexual experience for both parties.

Stays-Hard is an instant success

It is estimated that 300mn men worldwide suffer with erectile dysfunction problems and 30% of men will experience premature ejaculation at some stage in their life.

Current solutions such as pills, pumps and surgical procedures are known to be effective but are time-consuming and can cause long-term hassle and discomfort.

A new device however, created by British manufacturer Tyna International, has taken the OTC sex aid market by storm, promising to conquer erectile dysfunction and premature ejaculation, helping men sustain intercourse for as long as they wish.

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Though targeted at 40s-60 age group, it could also transform the sex lives of many men including the elderly and disabled without the need for invasive surgery. It could also help the estimated 7% of men in their 20s and 11% in their 30s who are suffering from erectile dysfunction.

Gaining global recognition, the device called ‘Stays-Hard’ holds the penis aloft to maintain an erection and can continue after orgasm. Safe to use with condoms and other contraceptives, the device can be fitted by either partner in a matter of seconds.

First going on sale last month, Stays-Hard sold out almost immediately, attracting strong interest from both customers and commercial distributors all over the globe.

Stays-Hard elongates the penis allowing for increased blood flow, it is comfortable, easy to use and pleasurable for both partners, giving a natural feeling.

After five years of research, the product was developed with advice from urologists and Professor Peter Ford of De Montfort University. A number of successful case studies in men of all ages confirmed Stays-Hard’s ability to maintain a pain-free erection, even after ejaculation.