Combination OTC painkillers gaining ground


Following the approved switch of Voltaren Arthritis Pain by the FDA in mid-February, there was more positive news for GSK’s US analgesics portfolio over the weekend with the FDA approval of Advil Dual Action. This is the first FDA-approved OTC combination of ibuprofen and paracetamol (acetaminophen) in the USA, and GSK is expected to launch the product later this year.

Franck Riot, Head of R&D at GSK Consumer Healthcare, said: “For decades, many consumers have been using ibuprofen and acetaminophen (paracetamol) to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain. Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option – a single, fixed-dose combination pain reliever.” According to the reported clinical research, this fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone.

dolostop plus

Dolostop Plus, another recent combination launch

Another combination OTC painkiller we tracked recently, formulated with both ibuprofen and paracetamol, is Kern’s September 2019 launch of Dolostop Plus in Spain. Indicated to provide symptomatic relief from mild to moderate pain in adults, these film-coated tablets are formulated with paracetamol 500mg and ibuprofen 150mg, with a stated dose of 1-2 tablets every 6 hours, and claimed to be the first and only OTC paracetamol and ibuprofen combination available in Spain.

In several markets around the world, such as the UK, Russia, Japan and Indonesia, combination paracetamol + ibuprofen OTC remedies are already well-established, but these recent developments in the USA and Spain point to growing acceptance among global regulators about the safety of fixed-dose OTC analgesic combinations.

Where will NPD take the CHC market in the future? Find out in our upcoming report, Innovation in CHC: NPD & Innovation in CHC under the Spotlight! This report, drawing on Nicholas Hall’s CHC New Products Tracker, assesses the global picture of CHC innovation in 2019, featuring ingredient trends, delivery format trends, analysing innovation trends by region and by marketer, plus much more! To pre-order your copy and save with the pre-publication discount, or for more information, please contact

OTCs in Action Episode 37: Supplements Shine in Scientific Studies

OTCinActionheaderThis week, dietary supplements are OTCs in Action, with Nicholas Hall & Company’s OTC.NewDirections e-bulletin last week reporting on promising scientific studies around the world. We also report on BLIS Technologies / Stratum’s success with probiotic health claims in Canada. From OTC.NewDirections:

  • Resveratrol is more effective in smaller doses at preventing bowel cancer in mice than high doses, according to University of Leicester and Lawrence Livermore National Laboratory scientists. Dietary doses (equivalent to one large glass of red wine) or doses 200x higher, were fed to bowel cancer-prone mice with a standard or high-fat diet. The lower dose produced a 50% reduction in tumor size, vs a 25% reduction with the higher dose in mice fed a high-fat diet. (Science Translational Medicine, July 29, 2015)
  • Probiotic supplementation may prevent infantile eczema, according to the Task Force on Probiotics of the Italian Society of Neonatology. A meta-analysis of 17 studies, involving 4,755 children, showed infants treated with probiotics had a significantly lower risk (22%) for eczema vs controls; infants treated with a combination of probiotics had a 46% reduced risk for eczema. (Allergy, July 21, 2015)
  • Researchers from Ljungby Public Dental Clinic, University of Copenhagen and Halland Hospital studied a group of 215 people, aged 60-102 years, who were given a lozenge containing two strains of Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) or placebo in the morning and evening for 12 weeks. Saliva and plaque samples showed that there was a statistically significant reduction in high Candida counts for both saliva and plaque in the probiotic group vs placebo. (Journal of Dental Research, July 22, 2015)

Investment in similar research by BLIS Technologies and Stratum Nutrition has led to the recent approval from Health Canada to make claims for BLIS K12 probiotics, including:

  • “promotes oral health (through the re-colonisation of the oral cavity)”
  • is an “oral probiotic for re-colonisation of the oral cavity after antibiotic treatment”
  • “following oral antimicrobial rinsing, Streptococcus salivarius K12 supplementation helps reduce volatile sulfur compound levels (halitosis)”
  • “can help reduce the incidence of Streptococcal pharyngitis / tonsillitis (sore throats caused by pathogenic variants belonging to the Streptococcus genus)”.

BLIS and partner Stratum’s focus on regulatory approvals is a means of opening up markets. “As arduous as the process is, each successful regulatory approval prepares the ground for the sales and marketing effort that follows,” commented Barry Richardson, CEO of BLIS. Last year, Prairie Naturals / Stratum’s CulturedCare Probiotic Gum using BLIS K12 was granted a product licence by Health Canada.