Allergan, Inc., has announced that it has received approval from the FDA to market the filler JUVÃ‰DERM VOLUMA™ XC to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. Allergan states that JUVÃ‰DERM 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. JUVÃ‰DERM 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 JUVÃ‰DERM 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 JUVÃ‰DERM VOLUMA™ XC was an effective treatment compared to the control group, which did not receive treatment.
JUVÃ‰DERM VOLUMA™ XC is made with Allerganâ€™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, JUVÃ‰- DERM VOLUMA™ XC contains a small amount of lidocaine, which helps to numb the treatment area during the injection procedure. The JUVÃ‰DERM VOLUMA™ formulation without lidocaine was first introduced in Europe in 2005. JUVÃ‰DERM 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.
JUVÃ‰DERM VOLUMAâ„¢ 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 TOLMARâ€™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 Impaxâ€™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 SÃ rl, a wholly-owned subsidiary of Celgene Corporation has announced results of its long-term phase III study on apremilast, the Companyâ€™s first-in-class oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic or biologic DMARD-naÃ¯ve 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-naÃ¯ve 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