FDA Approvals & News
FDA Approves Sculptra for Lipoatrophy
Sculptra (injectable poly-L-lactic acid) has now been approved by the FDA to correct shape and contour deficiencies caused by lipoatrophy in HIV patients — the only product with this indication.
In March of this year, the FDA’s Reconstructive Plastic Surgical Devices panel unanimously recommended Sculptra but cautioned that it should only be used for correction of lipoatrophy, which affects about half of all HIV-positive people, and not for cosmetic purposes.
Marketed as New Fill outside of the United States, Sculptra has been used in more than 150,000 patients in more than 30 countries around the world. Polylactic acid has been used for decades in products such as stents, dental implants and dissolvable sutures. It is a safe, synthetic and biocompatible material that’s injected below the skin.
Sculptra, which is manufactured by Dermik Laboratories, has a dual mechanism of action. At first, the product has a volume effect that’s secondary to the hydrogel volume injected. This effect lasts up to 1 week. The secondary delayed mechanism of action involves collagen synthesis, which occurs around 1 month following treatment. In clinical studies, effects with Sculptra last up to 2 years.

According to Reuters, Dermik expects Sculptra to be available by the third quarter of this year. In addition, parent company Aventis plans to eventually seek approval for a cosmetic indication for Sculptra in the United States.

FDA Advisory Panel Says “No” to Oral Tazarotene
Despite support from the National Psoriasis Foundation, numerous patients and many in the dermatology community, oral tazarotene (Tazoral) was not recommended for approval for treatment of moderate to severe psoriasis by the Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee last month by a 9 to 3 vote.
The advisory panel made its decision after citing concerns that the drug’s benefits weren’t greater than the potential adverse events, which could include severe birth defects if women using the drug become pregnant, as well as significant decreases in bone density.
In two of the main studies, fewer than 20% of patients exhibited improvement of their psoriasis, while more than 10% experienced significant decreases in bone density.
Reviewers on the panel also cited concerns that the drug might be prescribed off-label to acne patients and that it would be difficult to monitor those patients for risk of pregnancy. Despite Allergan’s willingness to implement a pregnancy prevention program, the FDA advisory panel indicated that these steps wouldn’t be enough to recommended approval.
The FDA panel advised Allergan to conduct larger and longer-term studies with Tazoral and to include more women in the studies. According to Reuters Health Information, Allergan officials said they would address the committee’s recommendations.

New Treatment for Basal Cell Carcinoma
The first prescription drug for superficial basal cell carcinoma (sBSC) in close to 10 years has received FDA approval. 3M Pharmaceuticals’ imiquimod (Aldara) cream, 5%, a topical immune response modifier, is now available for treating biopsy-confirmed, primary sBCC in adults with normal immune systems.
This approval falls on the heels of the company’s other recently FDA-approved indication for imiquimod, which was for the treatment of certain types of actinic keratosis on the face or scalp in adults with normal immune systems. 3M was granted approval for this indication in March of this year.
The new indication specifies that Aldara Cream can be used for the treatment of sBCC tumors with a maximum diameter of 2 cm, on certain areas of the body. This treatment can be followed only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.

Approval for the sBCC indication was based on data from two Phase III studies. These double-blind, placebo-controlled clinical trials involved 364 patients who had primary sBCCs. Patients who participated in the study had at least one biopsy-confirmed sBCC tumor, and they were randomly assigned to receive Aldara Cream or placebo cream once daily, five times a week for 6 weeks.
After 12 weeks of treatment, patients were assessed to determine the composite and histologic clearance rates. The results of the studies indicated that 75% of patients treated who were treated with Aldara Cream achieved composite clearance compared with 2% in the placebo group. In addition, the histological clearance rate was 82% for the Aldara group compared to 3% of patients in the placebo group.
The safety of using Aldara Cream for the three other types of BCCs has not been established. These types of BCC include nodular, pigmented fibrosing or sclerosing types.

New Indication Approved for Radiofrequency Device
Thermage received clearance from the FDA for its ThermaCool radiofrequency device for the indication to treat facial wrinkles and rhytids.
The device was already approved to treat periorbital wrinkles and rhytids, and according to Thermage, this full-face treatment indication is estimated to dramatically increase the demand for treatment with this device.
Approval for this indication was based on data from studies of 48 patients. The results of these studies showed substantially reduced laxity of the skin — many times after just one treatment. No adverse events were reported

Botox Receives New Indication
Botulinum toxin type A (Botox) received approval from the FDA for the treatment of severe primary axillary hyperhidrosis. The drug can be used for this indication if a patient’s condition can’t be managed with topical treatments, according to the FDA.
Approval was based on data from two Phase III clinical trials conducted in the United States and in Europe. In the U.S. study, 322 patients were randomized to one of three treatment groups. The first group of patients received
50 units of Botox per underarm (55%); the second treatment group received 75 units per underarm (49%) and the rest of the patients received placebo (6%). Improvement was graded as at least a 2-grade improvement using the hyperhidrosis disease severity scale.
Four weeks after patients received their first treatment, the results were as follows:
• 81% of patients in the group treated with 50 units of Botox experienced a more than 50% decrease in sweat production.
• 86% of patients who were treated with 75 units of Botox had a greater than 50% reduction in sweat production.
• 41% of patients who received placebo had a greater than 50% decrease in sweat production.

Adverse Events with “Permanent Makeup” Highlighted
The FDA issued an alert recently to draw attention to a number of adverse events linked to certain pigments contained in inks used for micropigmentation procedures.
The inks, which are manufactured by Premier Products, are used for tattooing to create permanent makeup for lip liner, eyeliner or eyebrow color. At least 50 adverse events have been reported so far, including swelling, cracking, peeling, blistering, scarring, and formulation of granulomas near the eyes and lips.
In some instances, the adverse events were severe enough to cause serious disfigurement that caused difficulty with eating and speaking. To view the specific inks involved in causing the adverse events, log onto the following FDA Web site: http://www.cfsan.fda.gov/~dms/cos-tat2.html.
If you suspect this type of adverse event, the FDA is urging healthcare practitioners to report problems to the nearest FDA district office. To locate the one nearest to you, log onto http://www.fda.gov/ora/fedstate/Smalbusiness/sbguide/regions.htm. Or, you may report the adverse reaction by calling the FDA’s Emergency Operation Center at (310) 443-1240 or the Center for Food Safety and Applied Nutrition at (301) 436-2405.

Should Drugs Be Prescribed for Off-Label Use?
A recent Wall Street Journal Online/Harris Interactive Health-Care Poll was conducted to find out what consumers know about off-label drug use and whether or not doctors should be able to prescribe drugs for uses not approved by the FDA.
The poll of 2,148 adults was conducted online in May, and it found that a 51% to 31% majority wrongly believes that a doctor can prescribe drugs only for the diseases for which they have been approved. The survey also found that 48% believe doctors shouldn’t be allowed to prescribe a drug for a disease for which that drug has not received FDA approval, and that pharmaceutical companies shouldn’t be allowed to encourage doctors to do so.

Fast-Spreading Antibiotic-Resistant Syphilis Strain
A study reported in a July issue of the New England Journal of Medicine claims there is a fast-spreading mutant strain of syphilis that is resistant to antibiotics pills, azithromycin, that are offered to patients instead of penicillin shots.
According to the study, researchers at the University of Washington in Seattle have found at least 10% of syphilis samples from patients at sexually transmitted disease clinics in four cities had a strain resistant to azithromycin. In San Francisco, the percentage of samples with the resistant strain rose from 4% in 1999 to 2002 to 37% in 2003. The increase was seen primarily in homosexual or bisexual men with multiple partners. Syphilis cases in general are on the rise, and the number of reported cases increased by 19% from 2000 to 2003, according to the Centers for Disease Control and Prevention.
When treating patients with this azithromycin-resistant strain, you should switch to penicillin or other antibiotics. Also, as you know, It’s also important to follow-up with patients treated with azithromycin to be sure they’re cured.