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New delivery for Cancer Breakthrough Pain


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Novel Technology Breaks Through Cancer Pain

From the PharmaLive.com News Archive - Aug. 16, 2007

MORRISVILLE, N.C., August 16, 2007 /PRNewswire/ -- Cancer patients fraught with flare-ups of pain, or breakthrough pain, may soon receive some assistance in the form of a new easy-to-use oral drug delivery system developed by BioDelivery Sciences designed to quickly deliver pain medication.

Cancer patients frequently experience two types of pain: persistent and breakthrough. Persistent cancer pain is characterized as continuous pain present for long periods of time, and often most of the day. Persistent pain is treated by daily or regular doses of pain medication.

Breakthrough pain is a brief and often severe shooting of pain that "breaks through" a patient's continuous medication for persistent pain. Breakthrough pain often has a rapid onset and lasts a short duration of time. It is called breakthrough pain because it "breaks through" a regular pain medicine schedule.

"Breakthrough pain is caused either by the cancer itself or the cancer treatment. For some patients, the pain is connected to certain activities, such as walking or dressing. For others, it occurs unexpectedly," says Dr. Andrew Finn, BioDelivery Sciences' VP of Product Development.

One breakthrough pain medication is the opiate fentanyl. Fentanyl is a potent opioid analgesic (painkiller) first developed in the 1950s, and long in use by the medical community for controlling various types of pain.

The next generation product able to quickly deliver fentanyl for the treatment of cancer breakthrough pain is a patient-friendly, small oral adhesive disc called BEMA Fentanyl, which has recently completed Phase III trials by BioDelivery Sciences. The BEMA technology is a very small layered disc that is applied to a mucosal surface (inner lining of the mouth) in a similar way a transdermal disc is applied to the skin.

The small disc is composed of an adhesive layer and a non-adhesive backing layer. The disc adheres to the inside cheeks and delivers the dose of medication quickly into the bloodstream. Instead of requiring removal upon completion of the drug delivery, the BEMA disc disintegrates in the mouth and leaves no drug residue.

The results of the Phase III pivotal efficacy clinical trial in cancer patients with breakthrough pain announced earlier this year with BEMA Fentanyl are very encouraging.

"The results of our study demonstrated that fentanyl could be delivered rapidly, effectively and easily using the BEMA technology," said Finn. "Besides allowing greater absorption of fentanyl, the BEMA disc was easier to use, as it only required seconds to apply."

It is estimated that at least 60 percent of people with advanced cancer will experience significant pain of some type, oftentimes including breakthrough pain. For more information on BEMA Fentanyl, log on to http://www.bdsinternational.com/

CONTACT: Bill Douglass, +1-212-825-3210, for BioDelivery Sciences

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BEMA Transmucosal Delivery Technology

BEMA delivery discs are water-soluble, bioerodable, cellulose-based pharmaceutical delivery devices for application to mucosal surfaces. BEMA devices deliver a rapid, reliable dose of their drug across mucous membranes (e.g. the mouth) for time-critical conditions like sedation and pain relief for cancer, or trauma cases where IV lines or injections are unavailable or not pratical.

The devices are composed of an adhesive layer and a non-adhesive backing layer, with both layers capable of holding the desired drug. Upon application, the disc adheres to the mucosal surface

and delivers the dose of medication. The BEMA system permits control of two critical factors for dose to dose reproducibility: 1) the contact area for mucosal drug delivery, and 2) the time the drug is in contact with that area.

In contrast to competing transmucosal delivery systems like lollipops and matrix-based delivery systems, BEMA products:

Adhere to mucosa in seconds, dissolve in minutes

Absorption is determined by the product, Do not require the patient to swish or move the product around in the mouth for absorption

Have a narrow, reproducible delivery rate, not susceptible to varying or intermittent contact with mucous membranes as with other systems

Dissolve completely, leaving no residual product or waste

Are inexpensive

BDSI's Current BEMA Products In Development

BEMA Fentanyl (Breakthrough Pain in Patients on Opioids)

There is a clear need for additional narcotic agents in alternative dosage forms to provide rapid pain relief.

BEMA Fentanyl is expected to meet the need for new narcotics and will be ideal for:

breakthrough pain in opiod-tolerant patients

post-operative patients following step-down from IV narcotics; hospitalized patients or outpatients without IV access

emergency rooms patients where available IV lines are limited or impractical

Other Buccal Products

Emezine™ (Anti-Emetic, Post-Operative Nausea, Oncology/Chronic Disease)

Postoperative nausea and vomiting (PONV) occurs in approximately 30% of patients undergoing operative procedures. Many factors influence the risk and severity of PONV. These include patient specific factors (age, gender), operative procedure (type and duration of procedure) anesthetic related factors (type and duration) and postoperative factors (presence of pain, oral intake). Although significant progress has been made in the prevention of symptoms, patients continue to have difficulty with PONV. Vomiting can result in dehydration, electrolyte imbalances, prolonged recovery room stay, hospital admissions and loss of work.

Anti-emetic agents are most effective when given prior to the surgical procedure or at cessation of anesthesia and frequently must be continued for several hours after the operative procedure. Products commonly employed for prevention and treatment of PONV are limited to dopamine receptor antagonists (droperidol, prochlorperazine) and serotonin receptor antagonists (ondansetron, granisetron, dolasetron, palonosetron). Dopamine receptor antagonists were the first agents used for PONV and remain the most effective agents.

Anti-emetic products are provided as injectable, oral and rectal formulations. Injectable products require that the patient be in a medical facility and have an intravenous injection line in place. Oral products have limitations because delayed gastric emptying that is associated with nausea and vomiting impedes the absorption of the product and actual product ingestion can be nauseating. Rectal suppositories are inconvenient as well as slow and unpredictable in onset. There is a need for alternative delivery systems.

BDSI's Emezine™:

Will be the first buccal anti-emetic in US market place

May offer predictability and speed of onset similar to IM injection

Avoids discomfort of injections & inconvenience of suppositories

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