Allergan, Inc., has announced that it has received approval from
the FDA to market the filler JUVÉDERM VOLUMA™ XC to temporarily
correct age-related volume loss in the cheek area in
adults over the age of 21. Allergan states that JUVÉDERM VOLUMA™ XC creates a more youthful appearance to the face and
provides natural-looking and long-lasting results up to two years
with optimal treatment. JUVÉDERM VOLUMA™ XC injectable
gel is indicated for deep (subcutaneous and/or supraperiosteal)
injection for cheek augmentation to correct age-related volume
loss in the mid-face in adults over the age of 21.
Allergan conducted a pivotal clinical trial in the United States
and Canada for submission to the FDA. The trial was designed
to assess the safety and effectiveness of JUVÉDERM
VOLUMA™ XC as a non-surgical option for patients desiring
volume in the cheek area to correct age-related volume loss.
The trial demonstrated that JUVÉDERM VOLUMA™ XC was
an effective treatment compared to the control group, which
did not receive treatment.
JUVÉDERM VOLUMA™ XC is made with Allergan’s proprietary
VYCROSS™ technology, a manufacturing process that results in a
smooth gel that flows easily and consistently. This unique formulation
contributes to the lift capacity to correct volume loss in the
cheek area and to the duration of the product. Additionally, JUVÉ-
DERM VOLUMA™ XC contains a small amount of lidocaine, which
helps to numb the treatment area during the injection procedure.
The JUVÉDERM VOLUMA™ formulation without lidocaine was
first introduced in Europe in 2005. JUVÉDERM VOLUMA™ with
lidocaine was first introduced outside the US in 2009.
The most common side effects observed in the clinical trial
included temporary injection-site tenderness, swelling, firmness,
lumps/bumps, bruising, pain, redness, discoloration,
and itching. They were predominantly moderate (uncomfortable)
in severity with a duration of two to four weeks.
JUVÉDERM VOLUMA™ XC will be available in fall 2013.
FDA Approval for Generic Solaraze
Impax Laboratories, Inc. and TOLMAR, Inc. have announced that
the FDA has granted final approval of TOLMAR’s Abbreviated
New Drug Application (ANDA) for its generic version of Solaraze®
Gel (diclofenac sodium-3%). TOLMAR was the first company to file a substantially complete ANDA containing a Paragraph IV
certification, and Impax’s generics division, Global Pharmaceuticals,
intends to commercialize this first-to-file product. The last
Orange Book listed patent expires August 11, 2015.
In June 2012, Impax Laboratories entered into a Development,
Supply and Distribution Agreement (the TOLMAR Agreement)
with TOLMAR, Inc. Under the terms of the TOLMAR
Agreement, TOLMAR granted Impax an exclusive license to
commercialize generic Solaraze in the United States and its
territories. Under the terms of the TOLMAR Agreement, TOLMAR
is responsible for developing and manufacturing the
product, and Impax is responsible for the marketing and sale
of the product. According to IMS Health (NSP), U.S. sales of
Solaraze® Gel 3% were approximately $78 million for the 12
months ended September 2013.
Oral Apremilast Monotherapy and Psoriatic Arthritis
Celgene International Sàrl, a wholly-owned subsidiary of
Celgene Corporation has announced results of its long-term
phase III study on apremilast, the Company’s first-in-class
oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic
or biologic DMARD-naïve psoriatic arthritis patients.
PALACE 1, 2, 3, and 4 are the pivotal phase III multi-center, double-
blind, placebo-controlled, parallel-group studies with two
active-treatment groups. In PALACE 1, 2 and 3, approximately
1,500 subjects were randomized 1:1:1 to receive either apremilast
20 mg BID, 30 mg BID or identically appearing placebo for 24
weeks, with a subsequent active treatment phase up to 52 weeks
followed by a long-term safety phase in which all patients are
treated with apremilast. The PALACE 1, 2, and 3 studies included a
wide spectrum of patients with active psoriatic arthritis, including
those who had been previously treated with oral DMARDs, and/
or biologic DMARDs, including patients who had previously failed
a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large
subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized
1:1:1 to receive either apremilast 20 mg BID, 30 mg BID,
or identically appearing placebo, for 24 weeks, with a subsequent
active treatment phase up to 52 weeks, followed by a long-term
safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2, 3, and 4 studies is
the modified American College of Rheumatology criteria for
20 % improvement (ACR20) at week 16. Secondary endpoints