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DARA BioSciences Continues to Support Patient Outreach and Education in Conjunction With Breast Cancer Awareness Month


October 31, 2014 - Raleigh, NC

RALEIGH, NC--(Marketwired - October 31, 2014) - DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments, announced its continued support of patient education and outreach to support Breast Cancer Awareness Month.

DARA has just released a video to help raise awareness of oral mucositis among patients with cancer, including the importance of proper oral hygiene and treatments to relieve the often intense pain associated with the condition. Oral mucositis is a common side-effect among cancer patients receiving radiotherapy and/or chemotherapeutic agents; both are used regularly in the treatment of Breast Cancer. DARA's product for the management of oral mucositis, Gelclair®, is indicated for the relief of oral mucositis pain.

The video, which features Dr. Elizabeth Feldman, DMD, MS, a maxillofacial prosthodontist and dental oncologist at UF Health Cancer Center-Orlando Health, and patient Ingrid Hellender, was created to help educate patients who suffer from oral mucositis on the steps they can take to insure appropriate pain management. Ingrid, a patient of Dr. Feldman, developed oral mucositis following her cancer therapy and began using Gelclair shortly after sores developed in her mouth. "Ingrid has had an excellent response to Gelclair, helping improve oral function, including pain relief and the consequent ability to swallow liquids and solid foods more easily, which are important benefits to insure proper nutrition in patients fighting cancer," said Dr. Feldman.

"Working with Dr. Feldman, an expert in the field of dental oncology, allows DARA to provide important education for patients with oral mucositis, and emphasizes the ability of Gelclair to help control the pain associated with this extremely uncomfortable side effect of cancer therapy," said Christopher G. Clement, DARA President and CEO. "We are very appreciative that Ingrid was open to sharing her story, to help educate the 400,000 patients who suffer from oral mucositis on an annual basis, and we look forward to continuing our efforts to educate and support the millions of cancer patients who suffer from cancer therapy related side effects on a daily basis," Clement concluded.

The video is a part of a series of educational materials DARA has developed to raise awareness of, and support, patients with oral mucositis. Earlier in the year, DARA released a Top 10 Oral Care Tips for Cancer Patients video, along with The Oral Mucositis Care app, available for iPhone and Android devices. The free app provides educational resources and useful tips for patients with oral mucositis.

About Oral Mucositis
Oral Mucositis (OM) is an acute inflammation and ulceration of the surface of the mouth and throat in cancer patients caused by chemotherapy and radiation treatment, which disrupt rapidly dividing epithelial progenitor cells. It is estimated that approximately 400,000 cases of OM are diagnosed annually. OM can be an intensely painful condition that often leads to difficulties swallowing food and fluids, potentially leading to dehydration and malnutrition. OM can also lead to delays in cancer treatments, through chemotherapy dose reductions, breaks in radiation treatment, cessation of cancer therapy, hospitalization and reliance on parenteral nutrition. OM is seen most often in patients receiving radiation therapy for head and neck cancer, and in patients receiving high-dose chemotherapy conditioning prior to hematopoietic stem cell transplantation. However, any patient receiving cancer treatment is at risk.

About Gelclair® (Bioadherent oral rinse gel)
Gelclair® is an easy-to-use bioadherent oral rinse gel indicated for the management and relief of pain of various etiologies, including oral mucositis/stomatitis, irritation due to oral surgery, ulcers caused by braces or ill-fitting dentures, certain systemic diseases, and for diffuse aphthous ulcers. Gelclair® has a unique hyaluronic acid -- based formulation and does not contain alcohol, thereby reducing the risk of painful burning and drying. Gelclair® has been broadly studied, demonstrating rapid and effective relief of pain, resulting in an improvement in patients' ability to eat and drink and reducing the need for rescue analgesics associated with oral mucositis pain. DARA has exclusive U.S. commercial rights to Gelclair® through a license with The Helsinn Group in Switzerland.

Gelclair® Important Safety Information
Do not use Gelclair® if there is a known or suspected hypersensitivity to any of its ingredients. No adverse effects have been reported in clinical trials, although post marketing reports have included infrequent complaints of burning sensation in the mouth. Do not eat or drink for at least 30-60 minutes following treatment. If Gelclair® is swallowed accidently, no adverse effects are anticipated. If no improvement is seen after 7 days, consult a physician.

For additional information, including a copy of the Full Prescribing Information, please visit our web site at www.gelclair.com

About DARA BioSciences, Inc.
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments.

DARA holds exclusive U.S. marketing rights to both Soltamox® (tamoxifen citrate) oral solution and Gelclair®. DARA licensed the U.S. rights to Soltamox® from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair® from the Helsinn Group in Switzerland. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%).

Soltamox® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, is indicated for the treatment of metastatic Breast Cancer, the adjuvant treatment of node-positive breast cancer in postmenopausal women, the reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS), and for the reduction of the incidence of breast cancer in women at high risk for breast cancer. Currently, there are more than 1.9 million prescriptions of tamoxifen written on an annual basis in the United States. Between 31 and 60 percent of patients fail to complete their prescribed course of treatment, thereby diminishing its benefits in reducing the risk of breast cancer recurrence.

Tamoxifen Important Safety Information
Tamoxifen citrate is contraindicated in women who require concomitant coumadin-type anticoagulant therapy, in women with a history of deep vein thrombosis or pulmonary embolus, and in women with known hypersensitivity to the drug or any of its ingredients. Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. The most common adverse reactions to tamoxifen treatment are (incidence > 20%) hot flashes, fluid retention, vaginal discharge, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal events.

Tamoxifen carries the following Boxed Warning:

WARNING -- For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of Breast Cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies in Prescribing Information.

The full Prescribing Information for Soltamox is available at www.soltamox.com/prescribing-information.

Gelclair® is an alcohol-free bio adherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. Gelclair should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%) a topical treatment for skin irritation and burns associated with radiation therapy, in U.S. oncology/radiology markets. Bionect should not be used by patients with known hypersensitivity to any of its ingredients. For further information on Gelclair and Bionect and the Full Prescribing Information please visit www.Gelclair.com and www.Bionect.com.

In early 2014, DARA kicked off its new partnership with Alamo Pharma Services, a subsidiary of Mission Pharmacal, in deploying a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA's products Soltamox, Gelclair and Bionect, this specialized oncology supportive care sales team also provides clinicians with access to three Mission Pharmacal products: Ferralet® 90 (for anemia), BINOSTO® (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis), and Aquoral® (for chemotherapy/radiation therapy-induced dry mouth).

Important Safety Information and full Prescribing Information for Mission Pharmacal's products may be found at: www.Ferralet.com, www.Binosto.com, and www.Aquoral.com.

DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and has granted DARA two separate Orphan Drug Designations for the treatment of multiple myeloma and for the treatment of painful, chronic chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics (CCIPN).

For more information please visit our web site at www.darabio.com.

CONTACT
Corporate Contact:
Jim Polson
FTI Consulting
312-553-6730
Jim.polson@fticonsulting.com

Media Contact:
David Connolly
LaVoie Health Sciences
617-374-8800, Ext. 108
dconnolly@lavoiehealthscience.com

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