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Poland Switches from Rx-To-OTC Mylan's Duspatalin for IBS, Plus Orion's ED Treatment

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Poland Switches from Rx-To-OTC Mylan's Duspatalin for IBS, Plus Orion's ED Treatment No. 23 • 10 June 2019 recommended posology is one tablet, three times per day, preferably 20 min- utes before meals. The product’s patient information leaf- let advises users not to take Duspatalin for more than five days without medical advice, adding that if there is no improve- ment in symptoms in this period, they should consult their doctor. Mebeverine is not widely available OTC across Europe, with the UK, Ireland and Belgium the only countries in the region permitting the non-prescription sale of the drug. VALINGER SWITCHED TO TREAT ED Alongside Duspatalin, URPL has also approved the Rx-to-OTC switch of Ori- on’s Valinger, making the erectile dys- Poland Switches from Rx-To-OTC function treatment sildenafil available without a prescription in tablet form. Mylan’s Duspatalin For IBS, In 2016, Polish men became the first in the world to have OTC access to silde- nafil when URPL switched Adamed’s Plus Orion’s ED Treatment MaxOn Active. TOM GALLEN [email protected] Valinger 25mg is indicated for use in patients over 18 years of age suffering oland’s national medicines regula- In 2016, Polish men from erectile dysfunction, with a maxi- tor, URPL, has approved two pre- mum recommended dose of 1 tablet per Pscription-to-OTC switches to give became the first in the day. The product’s patient information consumers easier access to treatments for leaflet advises users to complete a ques- irritable bowel syndrome (IBS) and erectile world to have OTC access tionnaire supplied with each pack to as- dysfunction. sess their suitability, and educate them Consumers can now purchase without to sildenafil when URPL about sildenafil and its contraindications. a prescription Orion Corp.’s Valinger (silde- switched Adamed’s Sildenafil remains non-prescription nafil), and from 1 July, Mylan NV’s Duspa- in all European countries except Poland talin Gastro (mebeverine hydrochloride). MaxOn Active. and the UK. Last year, Pfizer launched The switch of Mylan’s Duspatalin means Viagra Connect, the first OTC sildenafil- Polish patients will be able to access for based erectile dysfunction treatment the first time without a prescription the available in the UK. (Also see “Viagra Con- antispasmodic mebeverine to treat ab- for use in patients over the age of 10 nect aims to remove ED stigma” - HBW In- dominal pain caused by IBS. years suffering from abdominal pain sight, 11 May, 2018.) Duspatalin 135mg will soon be avail- or discomfort, which may be accompa- able OTC in packs of 15 tablets indicated nied by a change in stool constancy. The Published online 31 May 2019 FOR THE LATEST INSIGHT ON OTC, DIETARY SUPPLEMENTS AND COSMETICS VISIT: HBW.PHARMAINTELLIGENCE.INFORMA.COM HEALTH BEAUTY WELLNESS Thinking About Switching? Dr Gauld Blood In The Water? L’Oreal Hit VMS Industry Wants Into CBD Market, On The Go-To Markets Today, p. 4 With New Keratin Fraud Complaint Plus Enforcement On Firms Already As Matrix Suit Advances, p. 7 There, p. 11 Global Regulatory and Compliance Insight for Fast Regulatory Approval Successfully navigate the complex world of Pharmaceutical Regulatory and Compliance with access to worldwide intelligence for approved and pipeline drugs. Tracking product progress from submission to approval, our exclusive network of worldwide analysts and journalists cover critical areas of regulatory insight and analyse the implications of worldwide developments on your business. Anticipate challenges, minimize risks and maximize opportunities. To fi nd out more, visit: www.pharmaintelligence.informa.com/ pink-sheet JN2181 Pink Sheet Advert HBW A4.indd 1 2019/06/05 12:57 20 4 14 18 Global Regulatory and inside: COVER / Poland Switches from Rx-To-OTC Mylan’s Duspatalin 22 Stada Health Report 2019: A Quarter Of Europeans Take For IBS, Plus Orion’s ED Treatment Supplements, France and Germany Sceptical About Compliance Insight for Health Gadgets Health 22 House Appropriators’ Report Tracks With FDA Concern 4 Thinking About Switching? About CBD Supplements Fast Regulatory Approval Dr Gauld On The Go-To Markets Today 6 J&J Wants To Inspire A Quitter Movement In The UK With Nicorette Campaign Successfully navigate the complex world of Pharmaceutical 6 Pfizer Feels The Heat As ThermaCare Recall Regulatory and Compliance with access to worldwide Spreads To Europe intelligence for approved and pipeline drugs. exclusive online content Tracking product progress from submission to approval, our Beauty exclusive network of worldwide analysts and journalists cover 7 Blood In The Water? L’Oreal Hit With New Keratin Fraud Association Updates: Cranz Returns To Lead BAH, Plus critical areas of regulatory insight and analyse the implications Complaint As Matrix Suit Advances News From WSMI, PAGB And ASMI https://bit.ly/2QS4ust of worldwide developments on your business. 8 ICMAD’s New President Is Mary Kay Alum With Former AESGP head Cranz steps in to lead BAH; WSMI calls on Globally Recognized Scientific Expertise Anticipate challenges, minimize risks and maximize WHO to back self-care; PAGB appoints Riddalls to regulatory role; and ASMI changes name. opportunities. 10 EWG Casts FDA’s Proposed Sunscreen Rule As Validation Of Longstanding Concerns UK Wellness Marketing Round-Up, May: 11 Wildflower Rep Before FDA Cannabis Panel: Unbeelievable Health, NattoPharma, Wren, Vitabiotics CBD’s Functional Purpose In Beauty Products? Er … And More https://bit.ly/2Xud0Az To fi nd out more, visit: Mental health supplements from Unbeelievable Health, www.pharmaintelligence.informa.com/ Wellness study supporting NattoPharma’s MenaQ7 vitamin K2 pink-sheet 12 VMS Industry Wants Into CBD Market, supplement, award for Wren Labs’ international activities, and more wellness launches. Plus Enforcement On Firms Already There 14 FDA Road To Decision On Expanding CBD Uses Starts With Weighing Impact On Existing And Future Use As Drug Trademark Reviews 16 FDA’s CBD Puzzle: ‘Criminals’ Continue Or Cosmetics Prohibition Ends And Research Grows https://bit.ly/2QTsnjt 18 Full Plate Of Dietary Ingredients In Latest Health And Wellness Products US Tariff Hikes On Chinese Imports https://bit.ly/2Xtrzo0 19 Supplement Firms Work On Mitigating Import Tariff Costs Before Raising Prices 20 FDA Prioritizes Vinpocetine Decison After Animal Study Shows ‘Developmental Toxicity’ HBW-Insight @HBWInsight hbw.pharmaintelligence.informa.com 10 June 2019 | HBW Insight | 3 JN2181 Pink Sheet Advert HBW A4.indd 1 2019/06/05 12:57 HEALTH (OTC DRUGS) Thinking About Switching? Dr Gauld On The Go-To Markets Today DAVID RIDLEY [email protected] hen it comes to innovation, prescription-to-OTC switching can be a “holy grail” for pharmaceutical com- Wpanies looking to grab consumer healthcare market share or extend the lives of blockbuster prescription drugs reach- ing the end of their patent periods. However, reclassification applications are not easy to navi- gate successfully, with regulators often erring on the side of caution when it comes to making medicines available without a prescription. In this first installment of a three-part series on the state of switching today, switch expert Dr Natalie Gauld talks to HBW Insight about what makes a country an attractive environment for switching and those markets leading the way. Future install- ments will look at the role of pharmacy in making switches suc- cessful and the barriers companies face when thinking about prescription-to-OTC reclassifications. As well as publishing numerous studies on switching – in- cluding studies on the barriers, enablers and benefits of switch- ing for industry, regulators and consumers – Dr Gauld has cals Ltd.’s Maloff Protect (proguanil hydrochloride and atova- been involved in driving many switches, including the first- quone, 250mg/100mg, in packs of up to 36 tablets), Pfizer’s in-world switch of Pfizer Inc.’s erectile dysfunction drug Viagra Viagra Connect (sildenafil citrate, 50mg, in packs of up to eight Connect(sildenafil) in the UK. tablets) and Leo Pharma AS’s Dovonex Psoriasis (50mcg/g cream in packs of up to 60g). (Also see “Viagra Connect hits Q: Which countries would you say are leading the way with UK shelves” - HBW Insight, 13 Apr, 2018.) So that was exciting, switching today? having three in one year. But now things have slowed down again, and we’ve even seen some reverse switches in the last A: I’m going to stay with the developed countries because they five years, such as diclofenac in the UK, emergency contracep- are the ones leading the way in switching with new products tives in Poland, and dextromethorphan in France. and new therapeutic areas. The UK seems reasonably active at Editor’s Note: Following the decision by Australia’s Therapeu- the moment, but many other countries have had fairly limited tic Goods Administration to reverse-switch codeine in 2017, there numbers of switches. For example, in Australia applicants have has been a wave of similar reclassifications of the drug across the been trying to get many products across the line, such as silde- world, including in France and New Zealand. Poland is considering nafil and also oral contraceptives. But so far these attempts a reverse-switch, and in the UK, the MHRA’s Opioid Expert Working have failed. However, Australia is about to implement a new Group is looking at codeine as part of a review of the risks of opioid system which could enable more switches to get approved. medicines, such as dependence and addiction. (Also see “OTCs Un- Following the path of New Zealand, Australia is seeking to in- der Threat In Europe: Calls To Reverse-Switch Codeine And Others In troduce an Appendix M restriction that introduces additional Poland And Ireland” - HBW Insight, 19 Mar, 2019.) criteria for supply beyond its current pharmacist-only cat- egory. (Also see “Australian Industry Welcomes Possible Oral Q: How important is culture in creating a progressive switch Contraceptive Switch” - HBW Insight, 11 Mar, 2019.) I think that environment? that’s going to help switch in Australia but there are still impor- tant barriers that remain, particularly with regards to immedi- A: Very important.
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