New Drugs: 2014

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Neal Bhatia, MD

Ted Rosen, MD

In this presentation, Drs Bhatia and Rosen bring us the latest information on drugs that are, or will be available to the practicing dermatologist.

Apremilast is an inhibitor of PDE4 and is currently in phase III trials for ankylosing spondylitis, psoriasis, and psoriatic arthritis along with orphan status for Bechet’s disease. A published case report for apremilast for lichen planus (Paul et al. JAAD, 2013) demonstrated that 30 percent of the patients experienced a 2-grade improvement. This study was, however, small in numbers, treatment time and dosages.

As Dr Tsao mentioned in his presentation, omalimuzab has demonstrated promising results for the treatment of chronic idiopathic urticaria.

Dr Bhatia commented on the new treatments for onychomycosis, and feels that we have a “flood year of antifungals this year.” What we need to know:

  • Naftifine 2% gel—tape strips show stratum corneum residual after 4 weeks
  • Luliconazole is approved
  • Efinaconazole and Tavaborole are not
  • Itraconazole 200 mg tablets with new dosing protocol
  • Ketoconazole gel (Xolegel) and Itraconazole tablets (Onmel) are back
  • Econazole Foam is coming

In a Phase II study of luliconazole cream 1 percent for the treatment of interdigital tinea pedis, the researchers found that complete clearance was 26.8 percent and 45.7 percent in subjects in the two-week and four-week treatment group, two weeks post-treatment. Four weeks post-treatment complete clearance rates were 53.7 percent and 62.9 percent, respectively. A phase II study of efinaconazole for toenail onychomycosis also demonstrated favorable efficacy. Tavaborole, representing a new class of anti-fungals, met all primary and secondary endpoints in the treatment of nail fungus when compared to ciclopirox lacquer.

Ketoconazole gel 2 percent has the same side effect precautions as oral products, on label, but these are doubtful. It’s important to remember that the brand name in some markets may be cheaper than the generic. Also of importance, rates of mycological cure and effective treatment (secondary efficacy endpoints) were observed in the Econazole Nitrate Foam 1% group relative to the Foam Vehicle in both phase 3 studies (P<0.001). Itraconazole (200 mg) (OMNEL)  is available with a new dosing protocol. In a study, 200 mg tablets were found to be noninferior to itraconazole 100-mg capsules at 52 weeks. The safety profile of Omnel is not statiscially different from that of itraconazole.

Dr Rosen began his section of this presentation discussing Pliagils (Lidocaine 7% + Tetracaine 7% Cream). Pliaglis is a topical, local analgesia for superficial dermatological procedures. It is applied 20-30 minutes for most minor procedures and 60 minutes for more major procedures and is available in 30,60 and100gm tubes.

Sitavig (acyclovir 50mg Buccal) is indicated for recurrent oro-labial HSV. The technology is a natural polymer derived from milk which adheres to the mucosa; therefore leading to high local drug concentration, but minimal blood levels. It is one tabe, applied within one hour of prodrome onset and reduces the duration of an attack by 0.5 days based upon a randomized controlled trial of 775 patients. Another advancement includes the approval of carbinoxamine maleate susp (Karbinal ER), which is a mildly sedating H1 antihistamine in an extended release formulation. It is used for the treatment of allergic rhinitis and conjunctivitis, uncomplicated urticaria, angioedema, and dermatographism. Aurstat Anti-itch hydrogel was also approved in early 2013 to treat the symptoms of atopic dermatitis and various dermatoses.

Old Drugs, New News:

  • Adapalene/BPO 1.2%/2.5% (Epiduo®)
    • Now FDA approved down to age 9
  • Desoximetasone 0.25% (Topicort®)
    • Now available as a spray
  • Ketoconazole 200mg tab (Nizoral®)
    • Severe limitations on use due to liver and adrenal toxicity, as well as drug interactions
  • Certolizumab pegol (Cimzia®)
    • Now approved for psoriatic arthritis

In conclusion, clinicians should pay special attention to the Nizoral FDA warnings published in July of 2013. (www.fda.gov) If you use it and there is any hepatotoxic event, that could cause a great problem as a practitioner.

In summary, the dermatology landscape is continuing to grow with promising new drugs and it is imperative to stay on top of the latest data.