CHC regulation: News from EFSA and FDA

The European Food Safety Authority has stated that its scientists “cannot currently establish the safety of cannabidiol as a novel food owing to data gaps and uncertainties about potential hazards related to CBD intake”. Following the submission of numerous applications under novel food regulations, the European Commission asked ESFA to give its opinion on whether CBD consumption was safe for humans. EFSA’s expert Panel on Nutrition, Novel Foods & Food Allergens (NDA) believes there is insufficient data on the effect of CBD on the liver, GI tract, endocrine and nervous systems and psychological wellbeing. While studies in animals show significant adverse effects especially in relation to reproduction, it is important to determine if these effects are also seen in humans.

In other notable CHC regulatory news, the FDA has placed Sanofi’s Actual Use Trial to support the Rx-to-OTC switch of ED treatment Cialis (tadalafil) on hold, owing to concerns about the protocol design. Cialis is the only PDE-5 inhibitor that offers men a choice when it comes to treatment for ED – for use as needed and for once daily use. The AUT has not yet recruited any patients, but Sanofi noted that it “continues to work with the FDA to move the programme forward and will engage the agency in upcoming meetings as it determines the next steps”.

Source: EFSA

Nicholas Hall’s Touchpoints: Why am I not surprised at the latest EFSA ruling on CBD? Even though the Chair of the NDA Panel, Professor Dominique Turck, has let a crumb of comfort drop from his high table when he said, “It is important to stress at this point that we have not concluded that CBD is unsafe as food”, the announcement will have disappointed an industry and the many manufacturers who have sunk millions into proving the unique benefits of this new class of consumer healthcare products. This is, after all, the organisation that won’t allow probiotics to be named as probiotics on packaging, although it seems to me highly significant that the authorities in Spain and Netherlands are leading the way to override this ridiculous ruling by the Dr.No’s at EFSA. 

In much the same way, California is pioneering the move for hemp-derived CBD to be treated as supplements and eventually brought under the DSHEA umbrella. This is another crumb of much-needed comfort at a time when the FDA seems in a state of paralysis regarding the regulation of medicinal cannabis. And I’m extremely concerned with the recent news that the FDA has stopped Sanofi’s Actual Use Trial for the switch of Cialis, which my good friend Mary Alice Lawless believes could be a threat to the whole switch process in USA.

Explore the best CBD and lifestyle launches from 2021 in the Innovation Showcase featured in our recent Innovation in CHC report. Drawn from CHC New Products Tracker, you can also explore innovation by marketer, region and country. To order your copy, or for further information, please contact melissa.lee@NicholasHall.com.

Future and Cooper in European MED3000 licensing agreement

Futura Medical has entered into an exclusive licensing agreement with French-based Cooper, a leading European independent self-care company, for the rights to commercialise its gel-based ED treatment MED3000 throughout the European Economic Area, UK and Switzerland (where it will be marketed as Eroxon). Under the agreement, Futura will receive an (undisclosed) upfront payment, as well as cumulative sales milestone payments and will manufacture and supply the product (through its 3rd party contract manufacturers) to Cooper. In compliance with EU competition law, the initial licence agreement term is five years.

Nicholas Hall’s Touchpoints: This is an outstanding product, which my colleague Ian Crook, who authored our recent Sexual Health & Fertility report, describes as: “The first clinically-proven topical device for erectile dysfunction.” He tells me that MED3000 has the potential to shake up the ED market and that Futura believes it has identified a significant unmet need for an ED treatment that is efficacious, well-tolerated and works within minutes.

Six months after securing its first licensing agreement with Co-High Investment Management in China and SE Asia (March 2021), Futura struck a deal with US-based specialty biopharmaceutical company m8 to exclusively develop and commercialise MED3000 in Brazil and Mexico. This latest deal with Cooper, covering EEA, UK and Switzerland, brings the marketer a step closer to a planned launch in Europe, after the product received CE mark approval as a Class II(b) medical device in May 2021. Several positive factors – medical device status, lack of an active ingredient (the brand’s mode of action utilises a unique evaporative mechanism) and the fact that once approved it will be available without a prescription – contribute to MED3000’s sizeable potential.

Sexual health is one of the most dynamic sectors in the CHC market and a product like this is “la crème de la crème”: unique features and benefits, excellent performance, easy to use, no appreciable side-effects and – above all – significant need and high unmet demand. It is with highly innovative new products like this that we can look forward to industry growth even greater than our latest 5.5% forecast (all channels of distribution).

ED products are among the categories analysed in our recent Sexual Health & Fertility report. With reviews of other key categories including contraception, menopause, FemTech and intimate care, the report also highlights key trends and NPD. For further details, or to place your order, please contact melissa.lee@NicholasHall.com.

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.

Rx-to-OTC switch outlook for 2020

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One of the factors contributing to lower global consumer healthcare growth in recent years has been a falling-off in Rx-to-OTC switch activity in key markets like Japan and the USA. Looking ahead, however, there are reasons to be positive. In December 2019, Sanofi CEO Paul Hudson cited the company’s “plans to accelerate the over-the-counter switches for Cialis and Tamiflu” in order to fulfil its ambition of growing faster than the CHC market over the mid-term. In light of the current coronavirus epidemic, the benefits of wider OTC access to flu remedies is all the more evident.

Sexual health is another category with huge Rx-to-OTC switch potential, notably erectile dysfunction medicines and daily oral contraceptives. Though the switch of Cialis (tadalafil) has been stuck at the FDA for several years now since its submission, sildenafil (Viagra) is enjoying ever wider OTC availability, especially in Europe. After switching in Poland in 2016, sildenafil was launched as Viagra Connect (Pfizer) in the UK in 2018 and will be launched OTC as Viagra Reseptfri in Norwegian pharmacies in early 2020.

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There is also renewed interest in OTC triptans for migraine. A handful of switches took place in the mid-2000s but were held back by OTC purchase limits (a 2-tablet emergency pack). Over the past year, various countries have again began discussing triptan switches including Australia, Ireland and Germany (which is expected to expand the number of triptan molecules in the OTC sector), though major expansion of the segment is unlikely without larger pack sizes.

All that said, reverse-switch remains a threat and one OTC ingredient of ongoing concern is codeine. In late 2019, New Zealand’s Medicines Classification Committee, following Australia’s lead, recommended that all codeine-containing medicines should be reverse-switched from OTC to Rx. In January 2020, citing “widespread concern about the abuse of codeine-containing preparations nationally and globally”, the South African Health Products Regulatory Authority said it is reviewing the scheduling status of codeine and codeine-containing medicines which are available without a prescription.

CHC.NewDirections is an e-newsletter sent every Tuesday, with a focus on innovation, science and regulationCoverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices and new delivery formats, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

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.

OTCs in Action: OTC for ED in Poland

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This week, OTCs are in Action in Poland, where Adamed is launching MaxOn Active (sildenafil 25mg, the active ingredient in Pfizer’s Viagra), the second market for legitimate OTC access to erectile dysfunction drugs. The first de facto OTC market for the ED category was New Zealand, where Douglas Pharma switched Silvasta in October 2014.

Of course, Rx drugs and dietary supplements for ED can be quite easily available “under-the-counter” (pharmacists dispensing without a prescription) or online in many markets around the world. However, some of these dietary supplement products can have serious and even deadly side-effects, and many feature unsafe ingredients from unscrupulous marketers looking to meet the product demand. Additionally, in many Emerging Markets, pharmacists are often the only healthcare providers accessible to consumers, so the “under-the-counter” trade is widely accepted.

In Poland, where MaxOn is available only in pharmacies, men are asked to take a test to determine safe use of the OTC when they purchase a 2-count pack for about $10.00. It’s estimated that about 1.7mn men in Poland experience ED, so OTC competitors will surely be keeping an eye on this first European OTC ED market.

It’s intriguing that the test to ensure consumer compliance is a like a first KISS (Keep it Simple, Stupid). The test asks consumers several questions regarding their use of drugs and about previous diseases. A man will have three possible answers to each question: yes, I don’t know or no. If the question is marked “yes” or “don’t know”, the patient should consult the doctor about use of the medicine.

Click the link below to see how men will self-test for MaxOn Active:

OTCs in Action Episode 32: ED in NZ, not .com

OTCinActionheaderIllegal internet sales of Rx and OTC drugs, as well as adulterated dietary supplements, put consumers at great risk. “Tainted Sexual Enhancement Products”, published on the FDA’s website, warns consumers:

“The FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement. Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Last week, this blog’s sister publication, OTC.NewDirections, reported that an international crackdown on  illegal internet trade of medical products yielded $81.8mn worth of items from 115 different countries, and 156 arrests. In the UK, a record $25.1mn worth of counterfeit and unlicensed medicines and 15,000 devices was seized, including potentially harmful slimming pills, erectile dysfunction, anaemia and narcolepsy tablets. The US FDA took action against 1,050+ websites that illegally sell potentially dangerous, unapproved Rx medicines and medical devices.

In fact, regulators around the world are playing a high stakes game of Whack-a-Mole, a popular arcade game in which players hit cheeky little moles with mallets, but as soon as one is knocked out another appears elsewhere.

WHACK A MOLE_0However, the risky business is driven by consumer demand, and now OTCs are in Action in New Zealand to satisfy those needs safely and legally. One of the more common unapproved ingredients in the FDA’s list of adulterated products is sildenafil, more commonly known by its legal Rx brand name, Viagra. The Rx-to-OTC switch of Silvasta (sildenafil) erectile dysfunction treatment in New Zealand was approved in late 2014. Men aged 35-70 years can purchase Silvasta without an Rx following a screening process with a trained pharmacist. This spring Nicholas Hall & Company awarded Douglas Pharma its top marketing award for the launch of Silvasta. A consumer campaign includes TV ads featuring an “everyday” man explaining that help is at hand from pharmacies without the need to see a doctor, while a pharmacy finder website directs men to the nearest outlet.

Another interesting development that will ensure consumer access to safer drugs is the UK’s new requirement that online medicine sellers must be registered with the Medicines & Healthcare products Regulatory Agency. They must display on every page of their website the new European common logo, which will be linked to their entry in the MHRA’s list of registered online sellers. The medicine being offered online must be licensed in the member state where the purchaser is based, and the seller must be legally entitled to sell medicine in accordance with UK legislation. Registered pharmacies can sell general sales list and pharmacy medicines or supply Rx-only medicines that they have dispensed against a prescription. Other retailers can only sell GSL (self-selection OTC) products. The penalty for disobeying the registration and logo rules is up to two years in prison, a fine or both.

In an somewhat related matter, as it affects consumer safety and appropriate use of OTC medicines by reducing illicit methamphetamine manufacture, Acura Pharmaceuticals has entered into an agreement with OTC cold remedy giant Bayer to license its IMPEDE technology. IMPEDE technology, which is available in the US in Acura’s Nexafed, has demonstrated significantly reduced yields of methamphetamine compared to traditional formulations in lab tests and has been associated with a reduction in meth labs in local markets of up to 90%. OTCs in Action covered the launch of Acura’s Nexafed Sinus Pressure + Pain (pseudoephedrine and acetaminophen) in February.

Episode 17: Outwitting meth manufacturers