Bentley Acetaminophen Technology Circumvents Taste, Dissolution Hurdles

Bentley Pharmaceuticals is discussing potential licensing deals with several major pharmaceutical companies to bring products using its acetaminophen delivery technology to market.

Although no specific timeframe has been set, OTC analgesics containing Bentley's patented form of acetaminophen will begin appearing on shelves as soon as any agreements have been finalized, the firm said.

North Hampton, N.H.-based Bentley noted that the likely terms of a deal would give it responsibility for manufacturing and supplying the acetaminophen, with marketing and distribution handled by its partner.

Results of a bioequivalence study comparing Bentley's proprietary form of acetaminophen with the acetaminophen found in both McNeil Consumer Healthcare's Tylenol and GlaxoSmithKline's Panadol showed Bentley's achieved peak blood levels in roughly half the time.

The study findings were presented by Bentley Chairman and CEO James Murphy at the Raymond James & Associates Healthcare Conference in Nashville Oct. 2.

Conducted in the UK, the study looked at 12 subjects who received either two 500 mg tablets or a 1,000 mg sachet of Bentley's acetaminophen dissolved in water, or two 500 mg tablets of either Tylenol or Panadol.

The researchers drew the subject's blood 14 times in a 24-hour period and found Bentley's delivery technology led to peak acetaminophen blood levels 26 minutes after dosing, compared to 48 minutes for Tylenol and 52 minutes for Panadol.

While the study size was small, Bentley noted it was adequate to provide conclusive data. However, a Phase IV follow-up study might be conducted after a product launches.

In addition to the faster onset of action and ability to dissolve in water, the company also stressed its technology provides a taste advantage over conventional acetaminophen delivery forms. While typical children's medications use heavy flavorings to mask acetaminophen's bitter taste, Bentley said its tablets or sachets have no taste when combined with water.

Another OTC candidate Bentley discussed at the conference is its topical clotrimazole 4% for the treatment of onychomycosis - fingernail and toenail fungal infections.

Murphy noted that several Phase I/II clinical trials being conducted at the University of Alabama are ongoing and show promising results compared to currently available Rx treatments.

The topical film is applied to the affected nails once a day and is washed off once a week using nail polish remover. The film delivers the clotrimazole through the nail plate and into the skin under the nail.

Preliminary results from the ongoing trials have shown results in as little as 30 days, with fungus completely clearing in three to six months. Moreover, unlike Novartis' Rx treatment Lamisil (terbinafine) and Janssen's Rx Sporanox (itraconazole), both of which can cause liver problems, no side effects have been detected with Bentley's drug, the company added.

Bentley said it would confer with FDA on the design of a Phase III study to be conducted in both the U.S. and Europe before submitting an NDA, but noted it is in talks with major pharmaceutical firms regarding licensing deals for the drug as well. A U.S. launch is probably at least two years away, the firm said.

Points in favor of OTC distribution are the drug's strong safety profile and easy dosing regimen, Bentley stated. Both Bayer Consumer Care's vaginal yeast infection treatment Mycelex 7 and Schering-Plough HealthCare Products' Gyne-Lotrimin 3 contain clotrimazole, as do certain SKUs in Schering's Lotrimin AF athlete's foot line.

Applying the drug topically also permits consumers to accidentally skip a day without severe consequences, since the drug is still in place at the site of the fungal infection.

The acetaminophen and clotrimazole 4% products would be Bentley's first OTCs in the U.S market. The company sells roughly six nonprescription cough/cold and nasal spray products in Europe through its wholly-owned subsidiary Rimafar, but has no plans to introduce any of them to the U.S. market.