FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

DEERFIELD, Ill., Jan. 27, 2016 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc., (Takeda) (TSE: 4502) today announced that the United States (U.S.) Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication.

"Our more than 20 years of leadership in gastroenterology has allowed us to provide another option that offers relief from heartburn associated with GERD in an orally disintegrating tablet," explained Thomas Gibbs, Senior Vice President, General Medicines, Takeda. "This new formulation expands the Dexilant Family and offers appropriate patients with GERD, who may struggle with swallowing capsules, a melt in your mouth alternative." 

In addition to Dexilant SoluTab, Dexilant is also available as a capsule. The capsule is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE) and the maintenance of healed EE in adults. Since being approved by the FDA, Dexilant capsules have been available for nearly 7 years with over 25 million prescriptions filled.

About GERD
GERD is a chronic condition commonly known as acid reflux disease. GERD can occur when the valve at the lower end of the esophagus, called the lower esophageal sphincter (LES), does not work properly. This valve opens to allow food and liquids to enter the stomach and closes to keep acid and food in the stomach. When the LES does not close as tightly as it should, or relaxes too often, it can cause stomach contents to get into the esophagus.

GERD affects about 20 percent of the U.S. population and is often characterized by frequent and persistent heartburn two or more days a week despite treatment and diet changes. Adults who have trouble swallowing pills may consider discussing an alternate formulation option, such as an orally disintegrating tablet, with their doctor.

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated for:

Healing all grades of erosive esophagitis (EE) for up to 8 weeks
Maintaining healing of EE and relief of heartburn for up to 6 months
Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
DEXILANT SoluTab (dexlansoprazole) 30 mg delayed-release orally disintegrating tablets are indicated for:

Maintaining healing of EE and relief of heartburn for up to 6 months
Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Two 30 mg Dexilant SoluTab are not interchangeable with one 60 mg Dexilant Capsule. Dexilant SoluTab should be taken at least 30 minutes before a meal. Do not break or cut. Dexilant SoluTab should be placed on the tongue, and allowed to disintegrate (melt). The microgranules should be swallowed without water and should not be chewed. Dexilant SoluTab may also be swallowed whole with water. Avoid use of alcohol when taking Dexilant SoluTab. See full prescribing information for additional administration options.

IMPORTANT SAFETY INFORMATION

DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products.
Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
Acute interstitial nephritis has been observed in patients taking PPIs, including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (vitamin B12).
PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop DEXILANT treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT.
Most commonly reported adverse reactions were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with DEXILANT may reduce antiviral effect. Avoid concomitant use of nelfinavir with DEXILANT. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with DEXILANT may increase toxicity of the antiretroviral drugs.
Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., drugs with pH-dependent absorption such as digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil [MMF], ketoconazole/itraconazole). Use DEXILANT with caution in transplant patients receiving MMF.
Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
A hyper-response in gastrin secretion in response to the secretin stimulation test may falsely suggest gastrinoma. Temporarily stop DEXILANT treatment at least 30 days before assessing to allow gastrin levels to return to baseline.
There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
Avoid concomitant use of DEXILANT with St. John's Wort or rifampin due to decreased exposure of DEXILANT.
Please see accompanying full Prescribing Information, including Medication Guide for DEXILANT.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.

About Takeda Pharmaceuticals U.S.A., Inc.         
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

The company has a commercial presence covering around 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of R&D focus include central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

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The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

SOURCE Takeda Pharmaceuticals, U.S.A., Inc.

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