ADHD

FDA approves Lilly's ADHD drug Strattera

Thu, 08 May 2008 06:59:56 -0400

Eli Lilly has won FDA approval of Strattera, a therapy designed to treat ADHD. Lilly says this is the first regulatory win for a non-stimulant ADHD drug in a market dominated by two stimulants--Adderall (Shire) and Ritalin (Novartis). And researchers say that the data indicates the drug works past the 3 o'clock bell and into the evening.

There is a slight increase of suicidal thoughts for children and teens in the data; .4 percent in the Strattera group compared to none in the control group. In adults there was no discernible increase in suicidal thoughts.

"The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD" said Thomas J. Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School. "This is critical as ADHD may be a life-long disease and effective long-term control of symptoms may mean improved outcomes in children and adolescents."

- check out the press release
- read the AP report

Blogster sees lessons in FDA approvable letters

Thu, 21 Feb 2008 06:59:54 -0500

The blogster Eye on FDA has tracked down and posted every approvable letter he's heard about for 2007. The crop of letters highlights some particular challenges for new drugs targeting ADHD, pain and depression. The 29 letters marked a record for the FDA, particularly for multiple letters covering the same therapy. "And even though we are in a severe "risk-averse" environment, one could say that efficacy was every bit as much a factor as safety in the 2007 crop of letters."

- read the blog report

Related Articles:
2007 FDA approvals. Report
FDA more friendly to approvable than approved. Report
'07 drug approval record raises worries. Report
Dry spell or parched desert for NME approvals? Report
New drug approval lags in 2007. Report

Cortex drops bid to test drug for ADHD

Thu, 11 Oct 2007 06:59:54 -0400

Cortex Pharmaceuticals says that the FDA has turned thumbs down on its INDA for a Phase IIb trial of CX717 for ADHD after reviewing its animal toxicology studies. Cortex says its asking FDA officials to inactivate the INDA for that indication. Studies of CX717 will go ahead for respiratory depression and its Alzheimer's disease PET scan.

- see the release from Cortex

Related Articles:
Cortex gets green light to resume Alzheimer's trials. Report
FDA hold lifted on Cortex drug. Report
Cortex shares plunge on CX717 failure. Report
Cortex names Varney new COO. Report

Read more on: ADHD

Noven garners $25M payday on sales milestone

Tue, 31 Jul 2007 06:59:55 -0400

Noven will pocket the second of three potential $25 million milestones outlined in its deal with Shire. Shire says that the ADHD drug Daytrana continues to rack up enough market share to trigger the payments, exceeding $50 million in revenue for the 12 months ended on June 30. Noven will get its third big milestone payment if Daytrana breaks the $75 million mark.

- check out the release
- here's the report from Tech Journal South

Related Articles:
Noven expands pipeline with $125M JDS buyout. Report
FDA rejects Noven's copycat version of Duragesic pain patch. Report
FDA approves Daytrana ADHD patch. Report

Cortex gets green light to resume Alzheimer's trials

Tue, 17 Jul 2007 06:59:57 -0400

Cortex Pharmaceuticals says it will resume a study of its lead drug for Alzheimer's after getting a green light from the FDA. The agency put trials of CX717 on hold last year after it voiced concerns regarding animal data. The drug is designed to strengthen the brain signals of patients and is also being studied for narcolepsy, ADHD and schizophrenia. Researchers say they will soon approach the FDA to gain approval for a Phase IIb trial of CX717 for ADHD.

- see the release
- check out the AP report on the trial

Related Articles:
FDA hold lifted on Cortex drug. Report
Cortex shares plunge on CX717 failure. Report
Cortex names Varney new COO. Report

Pfizer inks genetic license with Genizon

Mon, 15 Jan 2007 19:01:37 -0500

Pfizer has licensed the diagnostic rights involved in the genetic research of Genizon BioSciences in Alzheimer's, ADHD, and endometriosis. Pfizer is providing an unspecified upfront fee, research money and an equity investment. Genizon is retaining the therapeutic rights associated with its research on the Quebec Founder Population, which is being used to develop genetic markers to predict the risk of disease.

"We are excited about the broad scope and combined contributions of this collaboration," said Dr. John W. Hooper, president and CEO of Genizon. "We expect the results of this research to lead to earlier and more accurate diagnosis and improved health care for patients afflicted with Alzheimer's disease, ADHD and endometriosis."

- check out the release on Pfizer's pact

Related Articles:
Archemix and Pfizer forge discovery pact. Report
Scripps inks $100M research pact with Pfizer. Report
Pfizer strikes deal for UK's PowderMed. Report

ALSO NOTED: Shire drug gets second approvable letter; Galapagos acquires ProStrakan sub; FDA asks Allergan for more data; and m

Thu, 21 Dec 2006 19:01:30 -0500

> The FDA has issued its second approvable letter for Shire's ADHD drug Vyvanse. Report

> Galapagos has acquired ProSkelia, a French subsidiary of ProStrakan in a deal worth up to €45 million. Report

> Allergan has announced that the FDA has asked for more data on its eye pressure medication Combigan. Report

> The FDA has approved Novartis' Exforge for high blood pressure. Release

> Protiva Biotherapeutics has filed an appeal that seeks to overturn the BC Supreme Court's ruling that would permit Inex Pharmaceuticals Corporation to transfer the Inex-Protiva agreements to Tekmira Corporation without Protiva's consent. Release

And Finally... Drug reps will face a tough year in 2007. Report

FDA demands tougher warnings on stimulants

Mon, 21 Aug 2006 20:01:37 -0400

The FDA has ordered drug makers to warn physicians away from prescribing stimulants like Ritalin, Adderall and Concerta to adults and children with heart problems, according to a report in The New York Times. The agency is also warning that the drugs are linked to hallucinations experienced by one in a thousand children. "We're not trying to scare people out of using these drugs," said Dr. Robert J. Temple, director of the Office of Medical Policy at the drug agency. "Still, I would be extremely reluctant to put people with heart failure on one of these drugs." The warnings, which aren't as strict as an advisory committee suggested earlier this year, come after regulators determined that a number of people with heart defects died suddenly after taking the drugs.

- read this article from MarketWatch on the FDA's action

PLUS: Glaxo has added stronger warnings to the label on its ADHD drug Dexedrine. Report

Cephalon shares tank after Sparlon rejection

Wed, 09 Aug 2006 20:01:39 -0400

Cephalon's last bid to gain approval for its ADHD drug Sparlon was rejected by the FDA and the news helped push its shares down 12 percent in early trading. The FDA's formal rejection was heavily influenced by its concern that the drug may have caused a case of Stevens Johnson syndrome, a rare and deadly skin disorder. That same link was enough for an FDA expert committee, which had rejected Sparlon by a vote of 12 to 1. Sparlon is marketed as a therapy for narcolepsy under the brand name of Provigil. Company officials said they were disappointed by the FDA's position, noting that their own experts disagreed with the regulators' conclusion.

- read the article on Cephalon from MarketWatch

Cortex shares plunge on CX717 failure

Wed, 21 Jun 2006 20:01:39 -0400

Shares of Cortex Pharmaceuticals got hammered on Wednesday when the company announced that a Phase II study to determine its lead drug's effect on wakefulness failed to demonstrate a greater effectiveness than a placebo. The study simulated night shift work among subjects taking CX717 and was funded by the Defense Advanced Research Projects Agency. The results differed markedly from an earlier study, and Cortex says a difference in the way the studies were designed may have played a role in the disappointing results. Cortex plans to focus now on the therapy's effectiveness against ADHD.

"We also remain committed to the program in Alzheimer's disease as we await the results from our Phase II study in that disorder," said Dr. Roger Stoll, chairman and CEO of Cortex. "Moreover, we anticipate having the opportunity to conduct additional studies on sleep disorders with either CX717 or with CX701, a back-up compound that should enter clinical trials early next year."

- here's the AP report on the Cortex trial

SPOTLIGHT: CDC estimates reignite ADHD controversy

Wed, 24 May 2006 20:01:33 -0400

A study in the New England Journal of Medicine states that the CDC estimates that more than 3,000 patients taking ADHD drugs made a trip to the emergency room in 2004 after suffering an adverse reaction. Symptoms included heart attacks, irregular heart beats and chest pains. And more than half involved accidental overdoses that included children who took the drug even though it had not been prescribed to them. The safety of ADHD drugs has been hotly contested over the past two years after the FDA had received reports of more than 20 deaths linked to the drugs. Article (WSJ sub. req.)

Cephalon provides update on Sparlon

Tue, 18 Apr 2006 20:01:39 -0400

Cephalon has responded to an FDA committee's rejection of Sparlon--its experimental therapy for ADHD--by submitting new information that it believes could pave the way to approval. In a filing to the SEC on Tuesday, Cephalon said that it had notified the FDA that the skin ailment suffered by a patient in its clinical trial of Sparlon did not appear to be Stephens-Johnson syndrome.

An FDA advisory committee voted last month to recommend against Sparlon and said the drug developer needed to develop more safety data. That vote was based on fears of the suspected case of Stephens-Johnson syndrome, an adverse effect associated with drug reactions. The FDA is expected to make a formal decision on Sparlon by May 22.

- here's the report on Cephalon from TheStreet.com

FDA approves Daytrana ADHD patch

Thu, 06 Apr 2006 20:01:38 -0400

The FDA has approved Daytrana, the first patch for treating ADHD. The therapy was developed by Noven Pharmaceuticals and Shire, which has the global marketing license. The companies said the new treatment would be released in mid-2006. It's designed to be worn by children throughout the day, who will receive a steady dose of the therapy. That is intended to help young patients who would have trouble staying up with oral formulas. Noven received an up-front payment of $25 million and stands to gain up to $125 million in milestones.

- here's a MarketWatch report on the patch

FDA committee votes against ADHD "black box"

Wed, 22 Mar 2006 19:01:39 -0500

An FDA advisory committee has voted against requiring a "black box" warning for ADHD drugs. Instead of getting a tougher warning, the experts recommend that the drugs come with labels that are clearer and easier for people to understand. A separate FDA panel had recommended a black box warning due to the cardiovascular risks associated with the therapies. ADHD drugs are stimulants, which raise blood pressure and increase the risk of heart attacks. A number of psychiatrists had warned against the agency's toughest label, noting that the therapies are badly needed for effective treatment. Children with heart problems, they said, should be identified and not provided the meds.

- read this article from the Los Angeles Times for more information

FDA staffers question safety of Sparlon for ADHD

Tue, 21 Mar 2006 19:01:35 -0500

FDA staffers have raised questions about potentially serious health risks posed by Cephalon's Sparlon for ADHD. One staffer noted last year that the risks were too serious to permit approval and another raised questions about skin rashes associated with the therapy. Sparlon is currently sold as Provigil, a sleep drug. An FDA advisory panel meets on Sparlon tomorrow.

- read the report from the Kindred Times

FDA panel wants 'black box' on ADHD drugs

Thu, 09 Feb 2006 19:01:39 -0500

A federal advisory panel is suggesting that the FDA should require its toughest warning label for ADHD drugs like Ritalin. The recommendation came as a surprise to the FDA, which typically follows the advice of its advisory panels but isn't required to. One possible follow-up would be for the FDA to ask for advice from a separate panel. At issue are reports of heart disease that may be linked to the drugs. The agency has track the deaths of 25 people and 54 cases of serious cardiovascular problems among the many people taking the drugs. A "black box" warning could be removed at a later stage if follow-up studies failed to confirm the link.

- read this AP report for more information

ALSO: The U.K.'s Shire, which makes Adderall XR, immediately followed up with a call for further studies into ADHD therapeutics. Article

FDA troubled by deaths among ADHD patients

Wed, 08 Feb 2006 19:01:35 -0500

The FDA is considering new warning labels for ADHD drugs after tracking the deaths of 25 taking the therapeutics between 1999 and 2003. Nineteen of those deaths were among children. Another 54 cases of serious cardiovascular problems, such as heart attack, were also recorded. The FDA's Dr. Kate Gelperin says the deaths and reports of injuries suggest a link exists between the therapeutics and those side effects. The FDA's Drug Safety and Risk Management group is examining the best way to study the possible link. Senator Chuck Grassley of Iowa, though, swiftly criticized the agency for its slow pace at following up on the possible safety issues surrounding ADHD drugs.

- read this article from USA Today for more

SPOTLIGHT: FDA committee to review ADHD risks

Wed, 01 Feb 2006 19:01:33 -0500

An FDA committee is scheduled to meet in a week to review how the agency should best study the cardiovascular risks posed by ADHD drugs. Concerns were heightened by Canada's decision to pull Adderall XR from the market last year. Report

FDA staffer reverses course on ADHD patch

Thu, 01 Dec 2005 19:01:37 -0500

An FDA staff scientist has reversed himself on an earlier opinion about a patch used to treat ADHD, telling an agency expert committee that the therapy from Shire Pharmaceuticals and Noven Pharmaceuticals should be approved. On Thursday, the FDA released a document saying the patch should not be approved because it increased the risk of side effects such as muscle twitches, anorexia and insomnia. But FDA staff reviewer Robert Levin says that he now thinks the therapy was not as risky as believed earlier. Risks remain, he added, but at a lower level.

- see this report from The San Diego Union Tribune for more information

FDA: Cylert risks outweigh benefits

Sun, 23 Oct 2005 20:01:35 -0400

The FDA has determined that the overall risks posed by Abbott Laboratories' Cylert for ADHD outweigh its benefits. "The agency has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug," said an announcement on the agency's Web site. Abbott announced last March that it would stop making the drug because of declining sales.

- read this FDA alert for more