news

Voltaren approved for arthritis pain over-the-counter in the US

13
SHARES

Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.

The US Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults 18 years and older. This means that Voltaren Arthritis Pain has become the first and only prescription-strength, non-steroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the US.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

“For the millions of people around the world living with arthritis, joint pain and stiffness are daily realities,” said Franck Riot, Head of R&D at GlaxoSmithKline (GSK) Consumer Healthcare. “At GSK, we are committed to improving the quality of life of these people and today’s approval is progress towards this, providing consumers in the US with increased access to an effective, proven arthritis pain relief option. Voltaren is currently the number one OTC topical pain relief brand globally and we look forward to expanding its availability in the US.”

In addition, the Osteoarthritis Research Society International (OARSI) recently updated and expanded its guidelines for non-surgical management of osteoarthritis (OA) by developing patient-focused treatment recommendations. These updated guidelines recommend topical NSAIDs for individuals with knee OA. Of the non-core interventions assessed as part of this guideline update, topical NSAIDs were recommended more strongly than all oral analgesics due to favourable balance of consistent efficacy and minor transient side effects.

This approval was based on clinical data in hand and knee OA supporting the original prescription approval. The data demonstrated a consistent and appreciable onset of pain relief beginning as early as week one (as evidenced by appreciable improvements in pain symptoms across multiple pre-specified endpoints), the company said. 

Voltaren Gel, which GSK owns the rights to, is currently only available with a prescription in the US.

Share via
Share via