FDA accepts NDA for investigational extended-release oral formulation of hydrocodone/APAP
NEWARK, Calif. — Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155. MNK-155 is an investigational, extended-release oral formulation of hydrocodone and acetaminophen that has been studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. MNK-155 is formulated with Depomed’s Acuform drug delivery technology.
"We are pleased that the FDA has accepted the NDA for MNK-155 for filing, and we look forward to potential approval of this extended-release product," stated Jim Schoeneck, president and CEO Depomed. "Depomed’s proprietary Acuform drug-delivery technology is also being used … by Mallinckrodt in Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets, an extended-release oral formulation of oxycodone and acetaminophen approved for management of acute pain severe enough to require use of an opioid analgesic."
The NDA acceptance triggers a $5 million milestone payment to Depomed under a license agreement between Depomed and Mallinckrodt. Depomed is also entitled to an additional milestone payment of $10 million upon approval of the NDA and high single digit royalties on net sales of MNK-155, if approved.
Louisiana becomes sixth state to restrict DXM sales to adults
BATON ROUGE, La. — Louisiana on Tuesday became the sixth state to prohibit minors from purchasing over-the-counter cough medicines containing dextromethorphan as Gov. Bobby Jindal signed HB 514 into law.
“Over-the-counter cough medicine abuse raised my concerns because of the easy access teens have to the medicines,” stated Rep. Cameron, R-District 82, who sponsored the piece of legislation. “Prohibiting teens from purchasing these medicines on their own, without their parents’ knowledge, is one way to deter teens from engaging in this behavior."
"The passage of this legislation indicates the growing support in our country for laws to prohibit the sale of DXM to minors, which helps parents prevent their teens from abusing cough medicine," stated Scott Melville, president and CEO Consumer Healthcare Products Association. "While there is no one solution to this problem, restricting access is an important part of prevention along with encouraging parents to talk to their teens about the risks and to safeguard the medicines in their home."
According to the 2013 National Institute on Drug Abuse’s Monitoring the Future Survey, approximately one in 25 teens abuses DXM to get high.
CHPA also supports a national age-18 sales restriction bill introduced in the U.S. Senate and U.S. House of Representatives, the Preventing Abuse of Cough Treatments Act of 2013 (S. 644 and H.R. 3969)
Selling wellness: Price a secondary concern as consumers seek healthier lives
Today’s consumers are increasingly looking for ways to live healthier lives, and often their desire for wellness overrides the desire for lower prices, prompting them to shop a specific store or buy a particular brand. It’s a mega-trend that shows no signs of slowing, and those retailers that can successfully leverage the new wellness urgency stand to reap the benefits, according to the new GMDC whitepaper, “Selling Wellness Across the Entire Store: Opportunities to Monetize Better-For-You HBW and GM.”
The study, conducted by The Hartman Group, not only sheds light on how wellness is part of consumers’ lives today and tomorrow, but also outlines key steps that retailers can take to become wellness leaders in their market.
“Stores that help transform customers from curious, to interested, to committed buyers of wellness products raise their potential to ring up more wellness-first and price-secondary sales. This could drive more trips, bigger baskets and fuller margins,” according to the report. “Also, stores that earn wellness reputations can draw shoppers while focusing less on price. This is true across health, beauty, general merchandise and food categories where wellness plays a role.”
In looking at today’s wellness consumers, researchers found that not all shoppers are created equal, and separated them into three different buckets: core (13%), which is the most committed group of wellness buyers; periphery (25%), which focuses on price and convenience, and thinks of wellness in a perfunctory way; and mid-level (62%), who possess moderate knowledge of wellness and a desire to somewhat buy and live like core shoppers.
But before diving into how to tailor to the specific kinds of wellness buyers, it is interesting to note that consumers have a very broad definition of wellness. To them, wellness goes beyond foods and includes such products as hair and skin care, eye and oral care, vitamins and supplements, baby needs, children’s hygiene and toiletries, cosmetics, feminine hygiene and OTC remedies, as well as GM — including home cleaning, laundry detergent, books and plant and garden care.
And, according to researchers, retailers also can raise their wellness image by offering ways to help consumers improve quality of life, such as services, expertise, messaging and caring support.
“Foods are the foremost wellness products, so stores that can connect food and non-food categories in meaningful ways for customers make buying easier, and help shoppers associate more areas of the selling floor with wellness — for example, sugar-free foods and treats near the pharmacy for people with diabetes,” the whitepaper stated.
In other words, dovetailing a non-foods wellness platform with one in foods can help a retailer boost credibility and emotional appeal.
Bridge the gap
There’s the saying that goes, “you can lead a horse to water but you can’t make him drink.” Well, maybe you can with gateway categories and bridge products.
“Gateway categories are pivotal entry ways for consumers into the world of wellness. People buy these initially, and their experiences can shape positive attitudes toward categories, brands and items within specific wellness destination stores,” the whitepaper stated.
Researchers noted that a change in a person’s life, such as childbirth or care of an elderly parent, can prompt a gateway purchase.
To succeed, researchers recommend that retailers and brands make wellness prominent at the shelf and relevant to targeted shopper missions. Merchandise, message, package and label wellness items appropriately.
It also is important to understand the benefits of bridge products or transitional choices. For example, a laundry detergent user can transition from a brand’s classic version to one free of perfumes and dyes before jumping, if ever, to a totally natural alternative, the whitepaper stated.
“Novice wellness buyers don’t appreciate the attributes of core products, so transitional choices like these give them an intermediate step to buy into, and help sustain their personal evolution in wellness,” researchers stated.
Researchers suggested displaying bridge products with obvious benefits to help periphery shoppers move up in the wellness categories to the mid-level or beyond.
To summarize their findings, researchers outlined the top seven recommendations for ways to lead in wellness and set stores and brands apart from price-driven rivals:
- The easier stores make it for wellness to be a seamless part of shopping trips, the greater the retail success;
- Embrace a wide view of wellness when marketing, since the biggest wellness opportunities relate to lifestyles rather than to acute medical conditions;
- Cultivate an e-presence since the primary wellness audience is escalating its use of the Internet, social media and smartphones to find product information;
- Emphasize sustainability to advanced wellness buyers because they connect their own well-being with that of society and the environment;
- Keep current with changing attitudes toward categories since wellness consumers think differently over time;
- Generate traffic and shoppers’ embrace of wellness with modern environments that suit the kinds of wellness buyers a store draws; and
- Wellness means so much to so many that it outranks price as a purchase factor for the most evolved shoppers. Unlike shop-to-save habits that permeate much of the store and restrict retail performance, wellness fervor has risen as a profit source.