The Food and Drug Administration (FDA) has granted Fast Track designation to Teikoku Pharma’s TPU-006 for the management of postoperative pain.

TPU-006 is an investigational transdermal system containing dexmedetomidine, a selective α2-adrenergic agonist. A single application is expected to deliver dexmedetomidine for 4 days.

The FDA’s designation was based on data from a placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT02953054), which included patients with acute moderate to severe pain following unilateral bunionectomy. Findings showed that patients treated with TPU-006 had lower pain scores and used less opioid rescue medication compared with placebo.

The Company is also investigating the safety and efficacy of TPU-006 in a phase 2 trial involving participants who have undergone abdominoplasty (ClinicalTrials.gov Identifier: NCT04242407). Results from this study are expected in the third quarter of 2023.

“We are excited by the FDA’s decision to grant a Fast Track designation for TPU-006 to address a serious unmet need and serve as a meaningful therapeutic option for patients with postsurgical pain,” said Paul Mori, President and Chief Executive Officer of Teikoku. “We look forward to working closely with the FDA to bring TPU-006 to clinicians and patients as soon as possible.” The FDA has previously approved other forms of dexmedetomidine including an injectable product for sedation, muscle relaxation, and analgesia and a sublingual film for agitation associated with schizophrenia or bipolar disorder.

Yaral Pharma announced the launch of diclofenac epolamine topical system 1.3%, an authorized generic equivalent to Flector^®.

Diclofenac epolamine is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years of age and older.

Each topical system contains 180mg of diclofenac epolamine (13mg per gram adhesive) in an aqueous base. When applied to intact skin, the topical system provides local analgesia by releasing diclofenac epolamine into the skin.

The product is supplied in resealable envelopes, each containing 5 topical systems (10cm x 14cm) with 6 envelopes per box. The recommended dose is 1 topical system applied to the most painful area twice a day.

“Like Flector, Yaral Pharma’s diclofenac epolamine topical system 1.3% offers patients a non-opioid topical treatment backed by more than 30 years of clinical experience,” said Stephen Beckman, CEO, Yaral Pharma. “We are pleased to offer patients an accessible and affordable product that offers targeted topical pain relief and look forward to expanding our product line across a range of therapeutic areas in the months ahead.”

References

1. Yaral Pharma launches diclofenac epolamine topical system 1.3%. News release. Yaral Pharma. Accessed January 1, 2023. https://www.businesswire.com/news/home/20221230005209/en/Yaral-Pharma-Launches-Diclofenac-Epolamine-Topical-System-1.3.
2. Diclofenac epolamine topical system 1.3%. Package insert. Yaral Pharma; 2023. Accessed January 3, 2022. https://www.yaral-pharma.com/dam/jcr:d80a232e-a73c-4455-9415-abfe0d11c167/Prescribing%20Information.pdf.

The Companies were flagged for marketing the following products:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%;
• SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30g) and NumbSkin 10.56% Lidocaine Numbing Cream;
• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray;
• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray;
• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1; and
• Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap. 

According to the FDA, some of these OTC analgesic products may contain concentrations of lidocaine that are higher than what is permitted, which may put consumers at risk for serious injury, including irregular heartbeat, seizures, and breathing difficulties.  

The FDA states that consumers should not use OTC pain relief products with more than 4% lidocaine on their skin. Moreover, these products should not be applied heavily over large areas of skin or to irritated or broken skin. Consumers should also not wrap skin treated with these products with plastic wrap or other dressings.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”