In addition to acquiring and marketing pain relief products, Victory has also established a growing pipeline of clinical stage development programs focused on addressing the current challenges in pain management and related indications. Victory has chosen to focus on development programs that have a high likelihood for success by:

  • Introducing new strengths and product configurations of NAPRELAN® that provide additional flexibility and convenience to healthcare providers and patients.
  • Utilizing a 505(b)(2) regulatory approach to advance novel indications, innovative formulations, and patented combinations of previously approved products through the regulatory approval process.

Victory’s development strategy reduces development risk and cost, while providing innovative treatments for pain and related indications.

 

 

Pain and Inflammation Programs

New NAPRELAN® Tablet Strength:
Victory recently introduced a 750 mg tablet strength of NAPRELAN. This tablet strength provides therapeutic dose with one tablet, and it allows physicians increased dosing flexibility for the only once-daily, branded naproxen product on the market. These advantages will afford a greater number of patients the benefits of NAPRELAN.

NAPRELAN® Dose Card:
Victory also recently introduced a NAPRELAN Dose Card for patients who require relief from mild to moderate pain and inflammation associated with primary dysmenorrhea and acute tendinitis and bursitis. It is also designed for patients suffering from rheumatoid arthritis or osteoarthritis who may be receiving other therapies and need additional anti-inflammatory/analgesic activity for a limited time. The Dose Card provides a ten day, tapered dose regimen in a single blister pack, with three days of NAPRELAN therapy at the maximum daily dose of 1,500 mg (i.e., two 750 mg tablets), followed by a taper to 1,000 mg per day (two 500 mg tablets) for an additional seven days of therapy.

Novel Tramadol Formulation:
Tramadol prescriptions in the U.S. are growing approximately 20 percent per annum. This growth is in part due to tramadol’s less severe side effect profile relative to higher potency opioids. Victory recently in-licensed a novel tramadol formulation that will provide greater dosing convenience to patients. Victory is currently working with its development partner to obtain marketing clearance from U.S. FDA.

MGX006 Development Program:
Victory’s most advanced, internal development program is an antiemetic that utilizes a novel, rapidly-dissolving tablet dosage form. The marriage of a commercially-established, rapidly-dissolving formulation and a proven antiemetic offers significant advantages for patients suffering from nausea and vomiting from numerous etiologies. MGX006’s clinical studies have been completed, and U.S. FDA has accepted Victory’s NDA submission.

MGX001 Development Program:
Opioid analgesics are a highly-prescribed and effective class of drugs to treat pain. However, the occurrence of opioid-induced sedation (OIS) is a common side effect that can be debilitating for some patients. Victory is developing MGX001, a combination product containing an opioid analgesic and an atypical stimulant to treat chronic pain and associated OIS. The program has completed a Phase 2 clinical study which provided guidance relative to dose ranging and proof-of-concept for the MGX001 therapeutic combination to treat this novel indication and unmet medical need.