Cadila Pharmaceuticals and Altus Formulation Announce Successful Clinical Studies with TramaFlex Breakable Extended-Release Tablets

Successful Validation of Novel AmyloFlex^tmModified Release Technology Platform: New Safer to Use Value Added Tablets

AHMEDABAD, INDIA and LAVAL, QC / ACCESSWIRE / January 27, 2021 / Cadila Pharmaceuticals Limited (“Cadila“) and Altus Formulation Inc. (“Altus“) today announced the successful completion of human clinical studies with TramaFlex^TM breakable extended-release (ER) tablets, a novel value-added once-daily formulation of tramadol hydrochloride for the improved treatment of patients with moderate to moderately severe pain.

Developed by Altus using proprietary AmyloFlex^TM technology, human bio-equivalence studies conducted by Cadila demonstrated TramaFlex ER tablets are bio-equivalent to 24hr ER products available commercially in North America, Europe, and Asia. Unlike marketed brands that can rapidly release their entire contents if damaged, with potentially life-threatening consequences (dose-dumping), TramaFlex ER tablets maintain full extended-release performance when broken irrespective of how they are taken, with no dose dumping even with alcohol. Additionally, while commercial once-a-day products are available as 100mg, 200mg and 300mg tablets only, breaking TramaFlex generates new low starting dose 50mg tablets, for frail or lower weight individuals, and intermediate strength 150mg and 250mg tablets. Flexible dosing with TramaFlex provides smooth titration to meet the needs of more patients.

Commenting on the new results, Dr. Damon Smith, CEO of Altus said; “we are delighted with the news results from Cadila first as a validation of the AmyloFlex platform as a robust cost-effective extended- release technology for value-added products, but most importantly because TramaFlex tablets offer patients suffering prolonged pain a safer to use alternative that is more likely to work for them; we look forward to bringing TramaFlex to market”.

Sharing his optimism regarding the new study results, Dr. Rajiv Modi, CMD, Cadila Pharmaceuticals Ltd., said; “we are driven by research based innovation that provides care and affordable solutions to our customers. Our partnership with Altus allows us to leverage their unique Flexitab™ technology, ensuring cost-effectiveness and value-added formulations for patients”.

TramaFlex tablets and the AmyloFlex modified release technology platform are covered by issued and pending patents in N. America, Europe and Asia expected to provide protection until 2038. Altus is seeking additional licensees for TramaFlex and other AmyloFlex products (including its once-daily breakable formulation of the atypical anti-depressant trazodone) within and outside N. America.

About Cadila Pharmaceuticals Limited

Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India. Over the last six decades, the company has been developing and manufacturing pharmaceutical products in India and selling and distributing these in over one hundred countries around the world. The company is presently in more than forty-five therapeutic areas spread across twelve specialities.

For more information visit: www.cadilapharma.com

About Altus Formulation Inc.

Altus Formulation is a Quebec-based drug formulation and development company using its proprietary and patent protected drug delivery technologies to generate novel, differentiated and cost-effective new products for its partners and their patients. With a focus on Safer to Use™ formulations, Altus’ technologies include Intellitab™ clinically validated abuse deterrent technology, Flexitab™ breakable extended-release tablets and SmartCelle™ micellar technologies for intravenous and topical delivery of low solubility molecules.

For more information, please visit www.altusformulation.com

Media Contact:

M. Robert Bechard: Corporate Development and Licensing
bbechard@altusformulation.com
tel: (001) 514 817 2514

SOURCE: Altus Formulation Inc.

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