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Striverdi Respimat from Boehringer Ingelheim now available

BY Ryan Chavis

Image: Boehringer Ingelheim GmbH

RIDGEFIELD, Conn. — Boehringer Ingelheim on Wednesday announced that its Striverdi Respimat (olodaterol) inhalation spray in 5-mcg dosage strength is now available by prescription in pharmacies across the United States. The medicine is a once-daily treatment for airflow obstruction in patients dealing with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. It should not be used to treat asthma or acute deteriorations of COPD, according to the company.
 
"For over a half century, Boehringer Ingelheim has been a leader in discovering and developing new therapies for respiratory diseases. We're proud to build upon our respiratory heritage by bringing Striverdi Respimat to market as a new COPD maintenance treatment option," said Kathleen M. Dowd, SVP, marketing, Boehringer Ingelheim Pharmaceuticals. "Approximately 15 million Americans have been told by a healthcare provider that they have COPD, and we believe Striverdi Respimat will be a welcome option for providers and patients alike."
 
The company will offer a savings card that will allow most eligible patients to obtain the medication at no cost for a limited time, depending on their insurance coverage. The savings card can be found at Striverdi.com and can be activated at any pharmacy, the company said. 

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Jean Coutu Group: ‘Good’ Q2 results, eyes promotions and private label to further drive sales

BY Antoinette Alexander

LONGUEUIL, Quebec — Facing a competitive landscape, Canada’s Jean Coutu Group is ramping up promotional activity and working to build loyalty among younger beauty shoppers with its private-label brand.

“A good quarter, second quarter of fiscal 2015, in spite of the restrictive regulatory context in an environment that is [increasingly] competitive,” Francois Coutu, president and CEO of the Jean Coutu Group, told analysts during its second quarter conference call Wednesday morning.

In light of the rise in promotional activity among competitors, the Jean Coutu Group launched two promotions during the quarter and also launched a health-related initiative to help shoppers remain healthier during travel.

“We launched various dynamic programs, including two Super Weekends in May and August, where many door-crasher prices were announced,” said Coutu. “Increases in sales were significant during these two weekends. We also launched various content, which proved to be very popular with our clients.”

In addition, the company announced late last month a five-year partnership with the three Dufour-Lapointe sisters — Maxime, Chloé and Justine — to be the new ambassadors of its Personnelle Cosmetics private-label brand. As previously reported by Drug Store News, the partnership marks the first time the retailer has associated its private-label brand with a public figure.

“The three sisters are young, they are bright, they are healthy and a good image for our youngsters. We want to make sure that the young generation uses Personnelle brand, and that is something that we needed to work on,” Coutu told analysts. “With the three sisters, I think we make some strides there, definitely.”

To help shoppers stay healthy during travel, the retailer distributed free health travel kits to customers, which included information on how to stay healthy while traveling. The company distributed more than 20,000 of the kits to shoppers.

During the quarter, revenues climbed 3.2% to $674.4 million Canadian dollars. The company attributed the increase to overall market growth and the expansion of the PJC network of franchised store, despite the deflationary impact on revenues of the volume increase in prescriptions of generic drugs compared with brand name drugs, as well as the price reductions of generic drugs.

Net profit per share gains related to the investment in Rite Aid amounted to 28 Canadian cents during the quarter compared with 24 Canadian cents in the year-ago period, a 16.7% increase.

The Jean Coutu Group operates a network of 416 franchised stores under the banners of PJC Jean Coutu, PJC Clinique, PJC Santé and PC Santé Beauté. The PJC network’s retail sales, on a same-store basis, increased 2.4%. Pharmacy sales on a comp basis increased 2.7%, while the front end rose 1.6%.
 

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Teva advances development of abuse-deterrent hydrocodone bitartrate extended-release tablets

BY Michael Johnsen

JERUSALEM – Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission to the Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology, providing potential abuse-deterrent properties (CEP-33237) as allowed for fast-track designated products. Teva expects to complete the NDA submission by the end of 2014. 
 
CEP-33237 is an investigational, 12-hour, acetaminophen-free formulation of extended-release hydrocodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.
 
Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone.
 
“Teva understands the risk of opioid abuse is a societal challenge and one many healthcare professionals face in treating people living with chronic pain,” said Michael Hayden, president of global R&D and chief scientific officer at Teva. “While the science of abuse deterrence is rapidly evolving, we are pleased with the results of our HAL studies and the comprehensive clinical program that supports the NDA for CEP-33237.”
 
 
Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal.
 
In the intranasal HAL study, abuse potential was significantly lower for crushed intranasal CEP-33237 (45 mg) than for intranasal IR hydrocodone powder (45 mg) based on peak at-the-moment drug liking and peak overall drug liking.
 
In the oral HAL study, abuse potential was significantly lower for crushed CEP-33237 (45 mg) powder than for IR hydrocodone (45 mg) based on peak at-the-moment drug liking. Overall drug liking was also significantly lower for crushed CEP-33237 compared to IR hydrocodone.
 
In both studies, intact CEP-33237 showed similar abuse potential to placebo.
 
“The comprehensive clinical program supporting CEP-33237 is an example of Teva’s long-term commitment to advancing responsible pain care,” said Richard Malamut, VP global clinical development and therapeutic area head of pain at Teva. “While no product or technology can completely eliminate abuse, having both positive oral and nasal HAL data speaks to the potential of CEP-33237 as a chronic pain treatment option with abuse deterrence properties.”
 
Topline results from the CEP-33237 pivotal Phase III study announced on April 30, 2014 showed significant improvement in the treatment of patients’ chronic low back pain as measured by both weekly Average Worst Pain Intensity and weekly Average Pain Intensity scores. The full results from the Phase III trial will be presented at the 15th World Congress on Pain hosted by The International Association for the Study of Pain in Buenos Aires, October 6 to11.
 
CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence and dizziness.
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