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Horizon Pharma (HZNP) recently announced the launch of Duexis, a combination of ibuprofen 800 mg and famotidine 26.6 mg, indicated for rheumatoid arthritis (RA) and osteoarthritis (OA). The Center of Disease Control estimates the prevalence of RA and OA at over 28 million Americans. For Horizon, the market potential for Duexis is substantial, but in reality, the market penetration may be disappointing. Duexis prevents one ulcer for every 10 patients when compared to ibuprofen alone, but the data does not indicate that it prevents gastrointestinal bleeding. In addition, there are market forces that may prevent Duexis from gaining any traction in the RA and OA space.

Ibuprofen and famotidine, the active ingredients in Duexis, are available in multiple strengths on the shelves of your local pharmacy or by prescription. Ibuprofen 200 mg is sold over-the-counter by various generic manufacturers and under the trade names of Motrin by Johnson & Johnson (JNJ) and Advil by Pfizer (PFE). Similarly, famotidine is also available over-the-counter in 10 and 20 mg tablets from various generic manufacturers and under the trade name of Pepcid by Johnson & Johnson. Ibuprofen 400, 600, and 800 mg is available by prescription. Famotidine, by prescription, is available in the 20 and 40 mg tablet strengths. The same dosing regimen as Duexis can be achieved at a much lower cost with potentially the same therapeutic outcome.

Brand Name

Available Over-The-Counter

Available by Prescription

Duexis (ibuprofen and famotidine)

Duexis

No

Ibuprofen – 800 mg

Famotidine – 26.6 mg

Ibuprofen

Motrin, Advil

200 mg

400 mg, 600 mg, 800 mg

Famotidine

Pepcid

10 mg, 20 mg

20 mg, 40 mg

If taken three times daily, Duexis provides approximately 2,400 mgs of ibuprofen and 80 mgs of famotidine per day. The 80 mgs of famotidine is important because it is at this dose that data has demonstrated to reduce ulcers from non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen. Duexis delivers a fixed 800 mgs of ibuprofen – a dose that is considered on the higher end and may not be appropriate in many patients – while the generic over-the-counter/prescription combinations can deliver anywhere from 200, 400, 600 or 800 mgs per dose. Unlike Duexis, the amount of ibuprofen can be tailored to the needs of the patient. With famotidine, the patient can be instructed to take two of the 20 mgs over-the-counter tablets twice daily to achieve 80 mgs per day or by prescription, one of the 40 mgs tablets twice daily. Not only will it cost less for patients and insurance carriers to use the generic over-the-counter/prescription combinations, but the dosing regimen will be a lot more flexible for physicians and patients.

Other strategies exist to prevent stomach ulcers in patients taking NSAIDS, with some better than Duexis. Proton-pump inhibitors (PPIs) such as omeprazole or brand name Prilosec by Procter & Gamble (PG) are available over-the-counter and proven to be more effective than famotidine. In other patients, adding misoprostol or using Celebrex instead of ibuprofen are also viable options.

It will be difficult to justify using Duexis, especially when cost is factored in. Duexis will cost an estimated $150 per month. Equivalent, and in some cases, better generic therapeutic options are available at a fraction of that price. Looking further into the horizon, HZN-602 will encounter the same issues as Duexis. This time, it will be famotidine and Naprosyn, a different NSAID that is available over-the-counter and by prescription in generic form.

Source: The Sun May Not Rise At Horizon Pharma For Duexis