May 2015 | Volume 14 | Issue 5 | Features | 528 | Copyright © May 2015
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department
may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new
products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
FDA Approves Cynosure 532 nm Laser for Tattoo Removal
The FDA has approved the Cynosure 532 nm laser delivery
system that works with the company's PicoSure picosecond
aesthetic laser to create a dual-wavelength laser system for
removing tattoos of all colors. Cynosure reports that this
new wavelength laser improves removal of red, orange, and
yellow tattoo ink in fewer treatments than previous lasers.
KYTHERA ATX-101 (deoxycholic acid) Injection and Submental Fullness
KYTHERA Biopharmaceuticals, Inc. has announced that the
FDA Dermatologic and Ophthalmic Drugs Advisory Committee
has voted unanimously to support the approval of
ATX-101 (deoxycholic acid) injection for improvement in the
appearance of moderate to severe convexity or fullness associated
with submental fat in adults, also known as a double
chin. If approved, ATX-101 would be a first-in-class submental
contouring injectable drug.
The committee's recommendation, although not binding, will
be considered by the FDA as it continues its review of ATX-
101. If approved by the FDA, KYTHERA anticipates launching
ATX-101 in the second half of 2015.
ATX-101 is a patented formulation of a pure, non-animal
derived version of deoxycholic acid, a naturally occurring
molecule in the body that aids in the breakdown of dietary
fat. ATX-101 has been the subject of 19 clinical studies involving
more than 2,600 patients covering a span of ages (19-65)
and BMI (18-40). A New Drug Application (NDA) was submitted
to the U.S. Food and Drug Administration (FDA) in May
2014 and has a Prescription Drug User Fee Act (PDUFA) action
date of May 13, 2015. Additionally, KYTHERA has submitted
regulatory filings in Canada, Switzerland and Australia. If
approved, ATX-101 would be a less-invasive, non-surgical
option for the treatment of submental fullness.
Generic Version of Temovate
Actavis has announced that it has launched a generic version
of Fougera's Temovate® (clobetasol cream 0.05%) in the
U.S. Temovate® is a high-potency corticosteroid indicated for
the relief of the inflammatory and pruritic manifestations of
FDA Approves Radiesse
Merz North America has announced that Radiesse® (+) with
integral 0.3% Lidocaine (“Radiesse® Plus“) has received FDA
approval and is now available to US physicians. Radiesse® (+) provides the immediate lift of wrinkles and folds, stimulation
of natural collagen production, and the lasting results
that patients and physicians expect from Radiesse®, as well
as providing patients significant reduction in pain due to the
addition of lidocaine.
Radiesse® (+) injectable implant is an opaque, dermal filler
that contains a small quantity of local anesthetic (lidocaine).
Radiesse® (+) temporarily adds volume to help smooth moderate
to severe facial wrinkles and folds, such as nasolabial
folds. Radiesse® (+) is composed of calcium hydroxylapatite
(CaHA) microspheres suspended in a water-based gel carrier.
Radiesse® (+) is a robust filler providing high elasticity (G’)
and viscosity1. In a clinical study, 101 patients received
Radiesse® on one side of the face and Radiesse® (+) on the
other side of the face. Patients rated their pain on a scale of
0 to 10. On the scale, 0 was no pain and 10 was very severe
pain. Immediately after injection, patients rated their pain
about 6.7 on a scale of 0 to 10 for the side of the face injected
with Radiesse® compared to about 2.3 on the same scale for
the side of the face treated with Radiesse® (+). Sixty (60) minutes
after treatment, patients rated their pain about 1.1 on a
scale of 0 to 10 for the side of the face injected with Radiesse® compared to about 0.3 on the same scale for the side of the
face treated with Radiesse® (+).
Promius Pharma Launches Zenatane 30mg Dose
Promius Pharma, LLC has announced that ZENATANE™
(Isotretinoin Capsules USP) are now available in a 30mg
dose. Zenatane, AB rated equivalent to Accutane 30mg, has
been introduced in response to dermatologists who have
continued to request this strength of the drug.