Product
Kapidex (dexlansoprazole) delayed release capsules

Approval Date
January 30, 2009

Release Date
February 2009

Company
Takeda Pharmaceuticals North America

Class
Proton pump inhibitor (PPI)

Indication
Indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of Erosive Esophagitis (EE) and the maintenance of healed EE.

Active Ingredient
Dexlansoprazole

Marketing Strategy/Execution
Takeda has a lot of experience marketing PPIs with
lansoprazole (Prevacid). Their marketing campaign for Kapidex includes professional journal advertising as well a strong patient-focused strategy in and out of the physicians’ office utilizing standard education materials such as wall boards and video screens.

Physician Outlook
Takeda’s Kapidex (dexlansoprazole) is a promising new entrant to the upper GI market. Trial results show advantages over Prevacid on healing erosive esophagitis (the primary endpoint). Like other PPIs, however, Kapidex will likely face obstacles due to generic competition and the introduction of OTC PPIs.

–Laura Dragone, Research Director, GfK Healthcare

Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: Metoclopramide-Zydisa

Manufacturer: Salix Pharmaceuticals/Wilmington Pharmaceuticals
Indication: Diabetic gastroparesis

Active ingredient: Metoclopramide rapidly disintegrating tablet

Phase: Preregistration

Source: Wolters Kluwer Health

Recent MM&M Coverage
Product News

Pharmacology
Dexlansoprazole is an acid pump inhibitor that suppresses gastric acid secretion by specific inhibition of the (H+,K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production. Dexlansoprazole is the R-enantiomer of lansoprazole and is supplied as a dual delayed-release formulation for oral administration.

Clinical Trials
Two double-blind, active-controlled, 8-week studies were conducted in 4092 patients with endoscopically confirmed EE. Based on the LA Classification, 71% had mild EE and 29% had moderate to severe EE before treatment. Patients were given one of the following treatments: dexlansoprazole 60mg daily, dexlansoprazole 90mg daily, or lansoprazole 30mg daily. The primary efficacy endpoint was % healed at week 8 of treatment. In study 1, 87% of patients given dexlansoprazole 60mg were healed compared with 85% of patients given lansoprazole 30mg. In study 2, 85% of patients given dexlansoprazole 60mg were healed compared with 79% of patients given lansoprazole 30mg. Both studies demonstrated non-inferiority to lansoprazole.

A double-blind, placebo-controlled study was conducted in patients who successfully completed an EE study and showed endoscopically confirmed healed EE. Maintenance of healing and symptom resolution over a 6-month period was evaluated with dexlansoprazole 30mg or 60mg once daily compared to placebo. A total of 445 patients were enrolled; 66% of patients treated with dexlansoprazole 30mg remained healed over the 6-month period as confirmed by endoscopy. Dexlansoprazole 30mg demonstrated a higher median percent of 24-hour heartburn free days compared to placebo over the 6-month period.

A double-blind, placebo-controlled 4-week study was conducted in patients with a diagnosis of symptomatic, non-erosive GERD. Patients were randomized to one of the following groups: dexlansoprazole 30mg daily, dexlansoprazole 60mg daily, or placebo. A total of 947 patients were enrolled. Dexlansoprazole 30mg provided statistically significantly greater median percent of days with heartburn-free 24-hour periods (54.9%) over placebo (18.5%) as assessed by daily diary over 4 weeks.

Adverse Reactions
GI upset, abdominal pain, upper respiratory tract infection, flatulence.

Adults
=18yrs: Swallow whole, or sprinkle granules on 1 tbsp of applesauce and swallow immediately. EE treatment: 60mg once daily for up to 8 weeks. Maintenance of healed EE: 30mg once daily for up to 6 months. Symptomatic GERD: 30mg once daily for 4 weeks. Moderate hepatic impairment (Child-Pugh Class B): max 30mg/day.

Children
<18yrs: not recommended.

Precautions
Severe hepatic impairment. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions
Concomitant atazanavir: not recommended (may decrease atazanavir levels). May alter absorption of pH-dependent drugs (eg, ketoconazole, digoxin, iron, ampicillin). Monitor warfarin.