New medicine on the market — from the makers of Adderall XR. Their press release, below:

FDA Approval of VYVANSE™ as a Novel Treatment for ADHD

23 Feb 2007 - Basingstoke, U.K., Philadelphia, PA and Radford, VA – FEBRUARY 23, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d-amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication’s unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Additional information about VYVANSE and other Shire treatments for ADHD is available at www.ShireADHDTreatments.com.

ADHD Drug Makers to Warn of Side Effects

The Associated Press

Wednesday, February 21, 2007; 7:01 PM

WASHINGTON — Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

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On the Net:
Food and Drug Administration ADHD drug information: http://www.fda.gov/cder/drug/infopage/ADHD/default.htm

What if all our strategic choices played out and paid off just as we planned?  Or if they didn’t, they at least failed quickly with quickly with no doubt as to why?

Yeah, right.

The business reality is that important strategies often take time to sort out, and even then it’s not always clear what worked and what didn’t.

Take DaimlerChrsyler, for example:  Daimler-Benz bought Chrysler in 1998.  Now it’s looking like they’re going to sell.  Nine years and tens of thousands of jobs later, and it looks like they’re going to cut their losses.

Or take Boeing vs. Airbus:  Boeing bet billions that the future was in designing and building planes for hub-and-spoke travel, while Airbus bet on point-to-point.  In 2003-2005, it looked like Airbus was going to eat Boeing’s lunch.  Now?  Airbus and the monster A380 are behind schedule, over budget, and in the stock market doldrums.  Never give up, indeed.

Mind you, DaimlerChrsyler, Boeing, and Airbus are some of the world’s largest corporations.  Their big decisions are made through the aggregate wisdom (and idiosyncrasies) of many, many people including the marketplace which they cannot control.

But how about the rest of us who have sole responsibility for our companies’ big decisions?  When things get tough, how do we decide whether to "cut our losses" and not "throw good money after bad" or whether to, "never never never give up"?  And how does our ADDexec nature — with our power to see possibilities, our tendencies to hyper-focus, our predelictions for tying emotion to outcomes, our gravitation toward risk taking — help or hinder our ability to decide and then do the best thing?

More on this topic soon.

Here’s a new item I hadn’t heard about until today: Focus ADDult for Adult ADD, a herbal remedy from Native Remedies. According to the manufacturer’s site (NativeRemedies.com), the active ingredients are:

- Centella asiatica (main ingredient)
- Rosmarinus officinalis (Rosemary), and
- Panax Ginseng

Has anyone tried it?

Here are the product claims from the Amazon listing:

Focus ADDult for Adult ADD, Improve Concentration, 50ml, $27.90

Focus ADDult, a 100% natural and proven herbal remedy, is formulated to treat and relieve symptoms of Adult and Teen ADD without side effects and dangers of prescription drugs. With Focus ADDult concentration, focus and memory will improve and improvement should increase over time and with continued use. Youll notice you can think more clearly and in more focused way. Students and scholars should notice increased concentration span and ability to study effectively for longer time periods.

Being 100% natural, with no artificial preservatives, Focus ADDult for adults and teens, is non-addictive and has NO SIDE EFFECTS. It has become the formula of choice by thousands of satisfied customers around the world for treating Adult and Teen ADD.

Adults and teens who suffer from ADD have had to resort to prescription psycho-stimulant drugs with the dangers of addiction and side effects. A safe and natural alternative for adults and teens with ADD, Focus ADDult uses a specially selected therapeutic blend of herbs from around the world, specifically to address symptoms of Adult ADD. Be aware that lifestyle factors like diet, health and fitness levels will all play a part in concentration and overall cognitive functioning.

Obvious disclaimer: This ADDexecutive article does not constitute an endorsement of this product. The ADDexecutive would, however, love to know if anyone has tried it or knows more. Your comments are welcome, below.

Photo credit: Amazon.com. Click pic to enlarge.

Here is a story that I’ve seen over and over again:

A smart and ambitious ADDult* has spent years in the corporate world and is just dying.  Too much bureaucracy.  Too many idiots.  Too many rules.  Too few opportunities to use all my skills and reward all my interests.

"I can do this better on my own," he says.  And so he quits and starts his own business.

"Hooray!" he says.  "Finally, I can be everything I want to be and no one’s going to stop me!"

And sure enough, he gets plenty of what he asked for.  Every day he gets to juggle a dozen different things: production, client relations, planning, dreaming, sweeping the floor, all while working until 2 in the morning or only 2 in the afternoon if that’s his wish. 

And sure enough, he’s making some magic in the marketplace: his products are innovative, his clients have never seen a vendor so excited to be working with them, and his standards of excellence are unmatched.

But wait… that might not be the whole picture.

How are his bank accounts?  Are his books balanced?  Can he find his files when he needs them?  Is he on time for his meetings?  Does the IRS have all his 1099s?  Are his staff getting the guidance they need?

Are all his clients feeling the love, or only the ones who keep calling?  Is he sticking to his business plan, or getting distracted by any shiny penny?  Does he even have a business plan, or is that still over in the "good intentions" pile? 

In short, is our ADDult’s business solid, or is it waiting to fall like a house of cards?

This is the Song of the Small Business in the land of ADD.  In a good world, our striving ADDult finds a way to supplement and complement his ADD assets with people who can help him keep the company organized and structurally solid.  In a lesser world, he doesn’t.

If you’re an ADDult small business owner, which world do you want to live in?

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*The ADDexecutive doesn’t know who created the term "ADDult" but we would like to.  Please comment if you can help — we’d like to give proper credit.

“I don’t need time.  What I need is a deadline.”

– Duke Ellington.

As for me, it’s more like, "I don’t need inspiration.  What I need is a deadline."

What do you need to "get it done"?

Corporate America has a longstanding tradition of bosses wanting to look infallible, and staff not wanting to risk the bosses ire by pointing out mistakes.

And it’s a damned costly shame.  It doesn’t serve the boss, the staff, or the bottom line.

Your staff knows that they’re supposed to help you meet your goals.  Let them also know that you want to help them do their jobs well, and to make that happen, they need to help you be the best boss you can be.

Get their input.  Ask them to tell you when you’re not being clear, or when you seem to be doing something that doesn’t make sense, or when they need your time and attention to accomplish whatever mission you’ve given them.

And guess what — this isn’t just about managing ADD.  It’s about being a good boss all around.

————–

For one broader exploration of this theme, check out What is Servant-Leadership? at the Greenleaf Center for Servant-Leadership.

Also see "Managing your Boss"  in the Harvard Business Review January-February 1990.  This article, by John Gabarro and John Kotter, was considered groundbreaking when it came out just seventeen years ago.  We still have a lot of "old thinking" DNA about the boss-as-infallible.  A whole lot of not-very-useful DNA.

You’re the boss.  You tell other people what to do.  And there’s nothing wrong with that.

But when you’re the boss with ADD, do your part to make sure that your staff really understand what you want before you send them on their way.

Why is this extra important for bosses with ADD? 

Two reasons:

1.  There’s a strong chance that you’re not the most precise or complete communicator in the world. *

2.  Junior staff around the world are often guilty of not asking their bosses for more info even when they know they don’t completely understand what’s being asked of them.**

So explain want you want.  Check to make sure you’re understood.  And explain again if your staff still needs you to.  Extra work?  Not really.  Proverbs throughout time affirm the need.***

———–

* Why the surprised look?   You’ve got an ADD head that (a) already knows what you want and (b) doesn’t need to explain to itself how to get it since it’s not actually going to do the work.

** Yeah, yeah.  For what you’re paying them, they ought not act like sheep.  And maybe most of your staff doesn’t act that way, at least most of the time.  But some do at least some times.  So keep those times from costing you.

*** Remember the proverb "Measure twice, cut once"?  Good.  That’s one of them.  How about "Haste makes waste?"  You get the idea.

The ADDexecutive Forum — Share What You Know, Ask What You Don’t.

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All hail the business lunch: one of the best and most convenient tools we have for making personal connections with our clients and colleagues.

Unless we screw it up by spending half the meal ignoring them.

Do yourself a favor: if your eyes can’t help but notice every moving creature in the restaurant (attractive diners, wait staff with precariously loaded trays, people refilling their drinks, etc.), seat yourself with your back to the scenery.  It’ll help your business relations, and maybe even your digestion if you don’t spend your energy fighting off the distractions.