January 31, 2007
February 21, 2008
Topical analgesic (NSAID)
Topical treatment of acute pain due to minor strains,
sprains, and contusions.
Diclofenac epolamine 180mg; per patch.
DraftFCB Healthcare (professional)
Alpharma's ability to strengthen its position in the
pain-management space will depend on the launch of Flector Patch, a topical
NSAID approved for pain. The sales force has effectively doubled to 400 and is
sized for both the patch and the upcoming launch of Embeda, an abuse-deterrent
version of its morphine pain drug Kadian, slated to be filed in the first half
of this year. In addition to recruiting 200 mostly experienced reps in support
of the Flector Patch, Alpharma engaged 125 Ventiv contract sales reps and made
“significant” advertising and promotion outlays including med ed, sales support
and samples. Novartis stole a march on Alpharma with Voltaren Gel, another
topical NSAID also introduced in January. But Alpharma thinks its twice-a-day
patch stacks up well against the four-time-a-day Novartis gel. Two-thirds of
Alpharma's 400-person sales force is new and will require training. Whether the
patch, in-licensed from IBSA, will succeed in drawing patients currently
treated with oral NSAIDs and COX-2 drugs is unknown. But the launch is a
critical phase in Alpharma's transformation into a specialty pharma business
centered around pain management.
|Synth Non-Narc Analg alone US sales ($000s) last 5 years
|Source: IMS Health, Feb. 2008
Top 5 Synth Non-Narc Analg alone
|| '07 US sales total ($000s)
||'07 % sales growth over ‘06
|Source: IMS Health, Feb. 2008
Alpharma's Flector Patch is the first NSAID utilizing a
patch delivery system. Given its
indication for acute pain relief of minor strains, sprains or bruises—the
Flector Patch will compete with both the over-the-counter and prescription
therapies. The Flector Patch offers
convenience and an alternative to the oral NSAIDs for patients at risk for
--- Geoff Penney, VP, category business leader, GfK Market
Measures, Feb. 2008
Also in the Pipeline
(according to Adis R&D Insight)
Drug: EN 3269/Keofix
Manufacturer: Applied Pharma Research
Active Ingredient: Ketoprofen
Source:Wolters Kluwer Health
Top 60: Draftfcb Healthcare
Flector is a topical patch that contains 1.3% of diclofenac
epolamine, a non-steroidal anti-inflammatory drug (NSAID). It measures
approximately 10 x 14 cm. When applied to intact skin, it provides local
analgesia as the drug is released into the skin. Although the exact mechanism
by which NSAIDs alleviate pain has not been established, their ability to
inhibit the activity of various prostaglandins may play a role.
Following application of a patch to the upper inner arm,
peak plasma levels of diclofenac were noted 10-20 hours later. Diclofenac is highly protein-bound;
it is eliminated by both renal and hepatic mechanisms.
The efficacy of Flector Patch in alleviating acute pain was
demonstrated in two studies in patients with minor sprains, strains, and
contusions. Patients were randomly assigned to receive either the Flector Patch
or a patch that did not contain the active ingredient. In the first study,
patients with ankle sprains were treated once daily for 1 week. In the second
study, patients with sprains, strains, and contusions were treated twice daily
for up to 2 weeks. Patients treated with the Flector Patch were found to have
experienced a greater reduction in pain as compared to those randomized to
Skin reactions (eg, burning, dermatitis, pruritus), GI
events (eg, nausea, dysgeusia, dyspepsia), headache, paresthesia, somnolence.
Discontinue if rash or hepatic reaction occurs. See literature re: risk of
cardiovascular events, Stevens-Johnson syndrome, toxic epidermal necrolysis, GI
Use lowest effective dose for shortest possible duration.
Apply 1 patch to clean, dry, intact skin on most painful area twice daily. May
tape edges down if patch begins to peel off. Wash hands after application.
Remove during bathing/showering.
Aspirin triad/allergy. Perioperative pain for coronary
artery bypass graft (CABG). Non-intact or damaged skin (eg, dermatitis, eczema,
burns, wounds, lesions).
Advanced renal disease: not recommended. History of ulcer
disease or GI bleed, or risks thereof (eg, concomitant corticosteroids,
anticoagulants, smoking, alcohol use, prolonged NSAID therapy). Cardiovascular
disease or risk. Hypertension. Heart failure. Fluid retention. Impaired renal
or liver function. Monitor blood pressure and for thrombotic and GI events. Not
a substitute for corticosteroids. Avoid eyes, mucosa. Handle and dispose of
properly. Elderly (monitor renal function). Debilitated. Pregnancy (Cat.C;
avoid in late pregnancy). Labor & delivery. Nursing mothers: not
Avoid concomitant aspirin. May potentiate lithium,
methotrexate, warfarin. May antagonize antihypertensive (eg, ACEIs).
Concomitant diuretics, ACEIs: increased risk of renal decompensation.