• The Massachusetts Public Health Council, a division of the state's
Department of Public Health, released proposed regulations in December 2008 to
restrict the pharmaceutical and medical device industry's gifts and payments
to physicians and make these gifts and payments public. At press time, the
council had planned to hold public hearings for comments on these proposed
regulations.
The proposed regulations would require companies to adopt and adhere to the
state's requirements for salespersons who interact with health care
professionals, prohibit certain payments to health care providers, and
publicly disclose payments valued at $50 or more. These regulations were
drafted in accordance with laws passed by the state's legislature and signed
by the governor in August 2008.
• The FDA's Division of Drug Marketing, Advertising, and
Communications sent a warning letter to AstraZeneca in December 2008 regarding
an illegal marketing practice to promote its drug quetiapine
fumarate. The letter alleged that a telephone call made by a company
sales representative and follow-up materials mailed to a health care
professional made claims that quetiapine is effective in treating major
depression. However, the drug has not been approved for this indication, and
promoting unapproved indications by the manufacturer is prohibited by law. The
agency requested the company to stop disseminating these messages and
materials immediately.
• Also in December, the FDA requested that AstraZeneca submit
additional data to support the company's application to add major depressive
disorder as a new indication for quetiapine fumarate
extended-release tablets, according to a company announcement. The drug is
currently approved in the U.S. for treatment of schizophrenia and bipolar
disorder. AstraZeneca said it would evaluate the request and "provide a
response to the agency in due course."
• An oral-spray formulation of the prescription sleep aid
zolpidem tartrate (Zolpimist) was approved by the FDA for
short-term treatment of insomnia characterized by difficulty falling asleep,
the manufacturer of the product, NovaDel Pharma Inc., announced on December
22, 2008. In two clinical trials, the oral spray was shown to have
pharmacokinetic and safety profiles comparable to those for zolpidem oral
tablets.
• The Prescription Project, an industry watchdog organization led by
the nonprofit Community Catalyst and the Institute on Medicine as a
Profession, filed citizen petitions to the FDA on December 3, 2008, urging the
agency to exercise its authority to regulate direct-to-consumer (DTC) drug and
device advertisements produced as online videos. In addition, the agency was
urged to issue a guidance document for the industry to clarify and restrict
the content and scope of such advertisements.
The petitions specifically cited promotional videos on
YouTube.com
(about medical devices manufactured by Abbott Laboratories, Medtronic, and
Stryker) for not including all the disclosures and warnings required by
current DTC rules for print and broadcast media. The petitions also pointed
out that online DTC consumer advertisements are increasingly used by the
industry through various Web outlets.
• New warnings and adverse reactions were added to the labeling of the
prescript ion sleep aid ramelteon (Rozerem), according to an
FDA MedWatch announcement. Patients who experience angioedema from the drug
should not be rechallenged. Rare "severe anaphylactic, anaphylactoid
reactions" and "abnormal thinking and behavioral changes"
such as the worsening of depression, hallucinations, bizarre behavior, and"
sleep-driving" (described as a more complex form of
sleepwalking) were added to the "Warnings and Precautions"
section.
• Schering-Plough announced on November 24, 2008, that the
investigational drug asenapine was shown to be significantly
more effective than placebo in preventing relapse of schizophrenia in a
randomized, double-blind, controlled, phase 3 clinical trial. In the 26 weeks
of the trial, 47 percent of the patients taking placebo and 12 percent of
those taking asenapine relapsed, a statistically significant difference. The
386 patients enrolled in this trial had previously been stabilized on
asenapine for acute treatment of schizophrenia. The company's announcement did
not specify the number of patients in each treatment group.
• The long-acting injectable formulation of paliperidone
palmitate was shown to be more effective than placebo in treating
schizophrenia, according to results of a 13-week, randomized, double-blind,
controlled clinical trial conducted by its maker, Johnson and Johnson
Pharmaceutical Research and Development. The results were announced on
December 10, 2008. The primary outcome of symptom control was assessed with
the Positive and Negative Syndrome Scale (PANSS) total score.
Also, in a 53-week randomized trial, flexible-dose paliperidone palmitate
injection plus oral placebo was compared with long-acting risperidone
injection plus orally supplemented risperidone. The results indicated that
both regimens led to reductions in PANSS scores, but the statistical analyses
failed to prove that the paliperidone-plus-placebo regimen was at least as
effective as the injection-plus-oral risperidone regimen. The company planned
to conduct another phase 3 comparative trial of the two drugs using a higher
loading dose of paliperidone, according to the announcement.
In both clinical trials, the long-acting injection was given every four
weeks.
The oral tablet formulation of paliperidone is available in the United
States and Europe for indications of acute and maintenance treatment of
schizophrenia.
• An investigational agent known as LX6171, which was
being studied for treatment of age-associated memory impairment, failed a
phase 2 clinical trial, according to a December 12, 2008, announcement by
Lexicon Pharmaceuticals, the company developing the drug. LX6171 is a small
molecule that inhibits SLC6A7, a high-affinity L-proline transporter expressed
in synaptic vesicles and presynaptic membranes of glutamatergic neurons in the
central nervous system. Growing evidence from basic research suggests that the
glutamatergic signaling system has a critical role in memory and learning. In
the clinical trial, healthy elderly subjects with age-associated memory
impairment taking daily LX6171 for four weeks did not perform significantly
better in attention or memory tests compared with those taking placebo. Given
the disappointing results, the company indicated in the announcement that the
drug would be dropped from clinical development.
• A once-promising drug candidate being developed for treating
cognitive dysfunction in schizophrenia was dropped by Targacept Inc. and
AstraZeneca after disappointing results from a phase 2 clinical trial, the
companies announced on December 9, 2008. In the trial of 445 subjects with
schizophrenia, the agent known as TC-1734 did not show a
significant benefit compared with placebo. The molecule targets the nicotinic
receptor in the central nervous system.
• H. Lundbeck A/S announced on December 15, 2008, that the company was
initiating three phase 3 clinical trials to develop the investigational drug
nalmefene for treatment of alcohol dependence. Nalmefene,
formulated as an oral tablet, is an opioid receptor antagonist that
potentially reduces cravings for alcohol. ▪