Flector Patch

Product
Flector Patch

Approval Date
January 31, 2007

Release Date
February 21, 2008

Company
Alpharma

Class
Topical analgesic (NSAID)

Indication
Topical treatment of acute pain due to minor strains,sprains, and contusions.

Active Ingredient
Diclofenac epolamine 180mg; per patch.

Agency Roster
DraftFCB Healthcare (professional)

MarketingStrategy/Execution
Alpharma’s ability to strengthen its position in thepain-management space will depend on the launch of Flector Patch, a topicalNSAID approved for pain. The sales force has effectively doubled to 400 and issized for both the patch and the upcoming launch of Embeda, an abuse-deterrentversion of its morphine pain drug Kadian, slated to be filed in the first halfof this year. In addition to recruiting 200 mostly experienced reps in supportof the Flector Patch, Alpharma engaged 125 Ventiv contract sales reps and made“significant” advertising and promotion outlays including med ed, sales supportand samples. Novartis stole a march on Alpharma with Voltaren Gel, anothertopical NSAID also introduced in January. But Alpharma thinks its twice-a-daypatch stacks up well against the four-time-a-day Novartis gel. Two-thirds ofAlpharma’s 400-person sales force is new and will require training. Whether thepatch, in-licensed from IBSA, will succeed in drawing patients currentlytreated with oral NSAIDs and COX-2 drugs is unknown. But the launch is acritical phase in Alpharma’s transformation into a specialty pharma businesscentered around pain management.

The Market

Physician Outlook
Alpharma’s Flector Patch is the first NSAID utilizing apatch delivery system. Given itsindication for acute pain relief of minor strains, sprains or bruises—theFlector Patch will compete with both the over-the-counter and prescriptiontherapies. The Flector Patch offersconvenience and an alternative to the oral NSAIDs for patients at risk forgastrointestinal complications.

— Geoff Penney, VP, category business leader, GfK MarketMeasures, Feb. 2008

Also in the Pipeline(according to Adis R&D Insight)
Drug: EN 3269/Keofix
Manufacturer: Applied Pharma Research
Indication: Pain
Active Ingredient: Ketoprofen
Phase: III
Source:Wolters Kluwer Health

Recent MM&MCoverage
Account Wins
Product news
TheTop 60: Draftfcb Healthcare

Pharmacology
Flector is a topical patch that contains 1.3% of diclofenacepolamine, a non-steroidal anti-inflammatory drug (NSAID). It measuresapproximately 10 x 14 cm. When applied to intact skin, it provides localanalgesia as the drug is released into the skin. Although the exact mechanismby which NSAIDs alleviate pain has not been established, their ability toinhibit 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.

Clinical Trials
The efficacy of Flector Patch in alleviating acute pain wasdemonstrated in two studies in patients with minor sprains, strains, andcontusions. Patients were randomly assigned to receive either the Flector Patchor 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 secondstudy, patients with sprains, strains, and contusions were treated twice dailyfor up to 2 weeks. Patients treated with the Flector Patch were found to haveexperienced a greater reduction in pain as compared to those randomized toplacebo patch.

Adverse Reactions
Skin reactions (eg, burning, dermatitis, pruritus), GIevents (eg, nausea, dysgeusia, dyspepsia), headache, paresthesia, somnolence.Discontinue if rash or hepatic reaction occurs. See literature re: risk ofcardiovascular events, Stevens-Johnson syndrome, toxic epidermal necrolysis, GIulcer/bleed.

Adults
Use lowest effective dose for shortest possible duration.Apply 1 patch to clean, dry, intact skin on most painful area twice daily. Maytape edges down if patch begins to peel off. Wash hands after application.Remove during bathing/showering.

Children
Not recommended.

Contraindications
Aspirin triad/allergy. Perioperative pain for coronaryartery bypass graft (CABG). Non-intact or damaged skin (eg, dermatitis, eczema,burns, wounds, lesions).

Precautions
Advanced renal disease: not recommended. History of ulcerdisease or GI bleed, or risks thereof (eg, concomitant corticosteroids,anticoagulants, smoking, alcohol use, prolonged NSAID therapy). Cardiovasculardisease or risk. Hypertension. Heart failure. Fluid retention. Impaired renalor liver function. Monitor blood pressure and for thrombotic and GI events. Nota substitute for corticosteroids. Avoid eyes, mucosa. Handle and dispose ofproperly. Elderly (monitor renal function). Debilitated. Pregnancy (Cat.C;avoid in late pregnancy). Labor & delivery. Nursing mothers: notrecommended.

Interactions
Avoid concomitant aspirin. May potentiate lithium,methotrexate, warfarin. May antagonize antihypertensive (eg, ACEIs).Concomitant diuretics, ACEIs: increased risk of renal decompensation.