Healthcare company GlaxoSmithKline (LSE:GSK) (NYSE:GSK) reported on Monday the receipt of US Food and Drug Administration (FDA) approval for the Voltaren Arthritis Pain over-the-counter (OTC) product for the relief of arthritis pain, expected to be available in Spring 2020.
Following the US FDA approval, the company said its Voltaren Arthritis Pain (OTC) (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) becomes the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older) in the US.
This OTC approval of Voltaren Arthritis Pain will provide the nearly 30m Americans with osteoarthritisi over-the-counter access topical treatment option. Osteoarthritis (OA) is the most common form of arthritis and the pain can gradually worsen over time, said the company.
The US FDA approval of the company's Voltaren Arthritis Pain 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.
According to the company, the active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. It targets pain directly at the site and the amount of diclofenac sodium that is systemically absorbed from Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of diclofenac sodium.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML