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Provigil Orphan Drug

Provigil Causes High Blood Pressure - The Rise And Fall Of Provigil

Posted by Tubei on 2022-11-22

The average monthly increase was 0. Off-label use of lidocaine patch was dominated by patients with diagnoses related to non-neuropathic pain. Initially, the observed monthly increase in patients using lidocaine patch was Provigil Orphan Drug found far greater use of two products — lidocaine patch and modafinil — for off-label indications than for any orphan indications.

The prevalence and cost of unapproved uses of top-selling orphan drugs

Use of cinacalcet was dominated by its FDA-approved non-orphan indication, but showed an increase in off-label use during the study period. By contrast, imatinib use was mostly related to its FDA-approved orphan indications.

Thus, our hypothesis was only partially correct — statistically significant non-orphan and off-label use compared to approved uses was found in three of the Provigil Orphan Drug drugs we studied. The Orphan Drug Act has helped incentivize development of new drugs for rare conditions, Provigil Orphan Drug this study shows that there can be significant growth in off-label use of certain orphan drugs.

The lidocaine patch and modafinil were approved to treat conditions manifested by common symptoms — respectively, post-herpetic neuralgia pain and narcolepsy daytime sleepiness — which can be intractable and frustrating conditions for both doctor and patient [28] — [29].

Although their pre-approval studies enrolled narrow populations covered by the Orphan Drug Act, these Provigil Orphan Drug showed efficacy in managing such symptoms in one context, so physicians may have been quick to prescribe them for other patients with similar symptoms.

Similarly, cinacalcet was approved to treat laboratory abnormalities hypercalcemia and hyperparathyroidism found outside the populations for which it was originally approved. Perhaps as a result, physicians were less likely to consider using these drugs off-label.

The growth of these drugs into top-sellers may be explained by other factors as well. Patients who present with chronic symptoms, such as pain or fatigue, may learn about newly approved products through media accounts and request prescriptions from their physicians. Changes in unit costs also contributed to increases in spending on the study drugs.

Despite the substantial commitment of resources through the Orphan Drug Act and other government funding to assist in the development of orphan drugs, their cost remains an important policy issue. Enacting limited waivers from state and federal antitrust laws could allow insurance plans to Provigil Orphan Drug band together in negotiating groups to seek lower drug prices for expensive orphan drugs where no alternative therapies exist [33].

Another way to reduce rates of unapproved non-evidence-based used of orphan drugs would be to vary the cost Provigil Orphan Drug the drug based on the indication. For example, payers could charge low co-pays to patients prescribed the drug to treat their orphan condition, and correspondingly high co-pays for non-evidence-based use.

Applying such value-based insurance design to promote more appropriate use of orphan drugs, however, is limited by payers' ability to distinguish among the reasons that drugs are prescribed. As a result, orphan drugs are commonly priced the same for all indications.

Some payers have tried Provigil Orphan Drug use administrative pre-certification forms for this purpose, although pharmaceutical companies selling orphan drugs have been investigated for allegedly teaching physicians how to fill out these forms to ensure approval of the drug for off-label uses [34]. This study has certain limitations.

We studied top-selling drugs, so our conclusions do not generalize to all orphan-designated products. We also determined FDA-approved and non-approved uses from diagnosis Provigil And Depo submitted with billing claims from health care encounters. It is possible that some of the patients we identified as receiving a drug for unapproved indications may have had the indicated disease, but did not have a recorded diagnosis of it.

Finally, the study population used to identify trends in utilization and spending comprised elderly persons with complete drug coverage residing in two states, and low-income patients in the Medicaid program.

Our results may differ from other recipients of these agents. In this analysis, we Provigil Orphan Drug focused on off-label use, rather than evidence-based use. However, for one of the products, the lidocaine patch, we found that an overwhelming share of the prescriptions were for patients with diagnoses for non-neuropathic pain syndromes, where no rigorous clinical trial evidence supports its use.

Off-label use can have solid supporting evidence, and may be appropriate even in circumstances where gathering of supporting evidence can be difficult [35]. On the other hand, when non-FDA approved uses are not supported by adequate clinical evidence, patients do not receive the intended benefits from the drug, are less likely to be prescribed more effective treatments, and are exposed to risks of adverse events with no demonstrated countervailing benefits.

The substantial costs of orphan products to Medicaid add to the concern Provigil Orphan Drug off-label and non-evidence-based uses. For the drugs in our sample, greater attention to implementing value-based insurance design may help limit non-evidence-based off-label use [36]. These findings documenting off-label use in certain top-selling orphan drugs may have important implications for the Orphan Drug Act and for drug development policy.

Currently, generous orphan drug incentives in the US are earned during drug development or at the point of FDA approval, before the product reaches the market.

The Orphan Drug Act has proven useful in encouraging the government and pharmaceutical manufacturers to devote resources towards Provigil Orphan Drug new drugs for orphan conditions. Our data suggest that it might be preferable to continue to monitor orphan drug use after approval to identify products that come to be widely used for non-FDA approved indications — especially those for which there is also inadequate evidence of efficacy. Orphan drugs that quickly find widespread use are likely to provide an adequate return on investment to their manufacturers in a short time frame.

Proviggil such use occurs widely, it may be reasonable to terminate the orphan drug market exclusivity period. Another alternative would be to seek reimbursement of the considerable government investments made in orphan drug development on the expectation that these drugs would find only limited use.

The concept of reimbursing initial public investment in drug development remains controversial, although it has recently been endorsed by Francis Collins, Director of the National Institutes of Health [37].

Cephalon seeks to block generic version of Provigil

Finally, our study Ilaci Provigil that regulators may be able to take a more proactive step and predict certain orphan products Provigkl are likely to be widely prescribed for non-FDA approved indications — those initially designed and approved to treat common symptoms or laboratory abnormalities, albeit in the context of a Provigil Orphan Drug disease. For these products, it may be reasonable to withhold orphan drug status, and instead direct the limited resources of the program to encouraging development of novel products such as imatinib aimed at treating truly rare diseases.

Applying incentives selectively to developing such products would adhere more closely to the original goals of the Orphan Procigil Act. Browse Subject Areas? Click Provvigil the PLOS taxonomy to find articles in your field. Methods We assessed prescription patterns for four top-selling orphan drugs: lidocaine patch Lidoderm approved for post-herpetic neuralgia, modafinil Provigil approved for narcolepsy, cinacalcet Sensipar approved for hypercalcemia of parathyroid carcinoma, and imatinib Gleevec approved for chronic myelogenous leukemia and gastrointestinal stromal tumor.

Results We found Provigol prescriptions for Prpvigil patch, modafinil, and cinacalcet associated with non-orphan diagnoses rose at substantially higher rates average monthly increases in number of patients of Discussion In our sample, three of four top-selling orphan drugs were used more commonly for non-orphan indications. Introduction The Orphan Drug Act encourages the development of medications to treat rare conditions.

Methods Sources of data We studied Medicare beneficiaries enrolled in 2 large state-funded programs of medication coverage Provigip older patients: the Pharmaceutical Assistance Contract for the Elderly PACE program in Pennsylvania and the Pharmaceutical Assistance for the Aged and Disabled PAAD program in New Jersey from toPgovigil the introduction of Medicare Part D altered the availability of prescription use data through these state-based insurance programs.

Study population Participants Provigil Orphan Drug enrolled and active users of Medicare and either prescription drug benefit program for at least 6 months prior to their index date defined belowas demonstrated by the program eligibility files. Study drugs The top-selling Orphqn drugs by retail sales in included 12 approved for one or more Provibil indications [20].

Download: PPT. Table 1. Study drugs and FDA-approved indications — Results Off-label use of orphan drugs Figures just click for source23and 4 present the total number of patients filling prescriptions for each study drug by month and indication trends in new patients tracked these results data not shown.

Figure 1. The number of patients filling prescriptions for lidocaine patch Lidoderm for on- and off-label uses in two state drug benefit programs. Figure 2. The number of patients filling prescriptions for modafinil Provigil for on- and off-label uses in two state drug benefit programs. Figure 3. The number of patients filling prescriptions for cinacalcet Sensipar for on- and off-label uses in two state drug Povigil programs.

Figure 4. All participants in an n-of-1 trial have the opportunity to receive study drug, and individual level data are used to estimate a population effect. The FDA is supportive of methodological innovations Provkgil and hosted a conference on adaptive trial design. Still, there are doubts among drug sponsors and clinical researchers whether these alternatives can be successfully conducted, and concern exists that the FDA is not ready to evaluate them.

Orphan indication approvals and orphan drug designations have steadily increased since the signing of the Orphan Drug Act in Current scientific, economic, and regulatory forces suggest that approvals of therapeutics under the Orphan Drug Act will remain an important part of Druug and biotechnology pipelines in the years to come. First, research in the basic sciences continues to discover more refined disease targets and genetic causative factors. As a result, the number of recognized rare diseases and the spectrum of neurological therapeutics will probably increase, opening avenues for new orphan drug designations.

Second, the financial incentives of the Orphan Drug Act are still attractive to pharmaceutical and biotechnology companies. Although these are isolated cases among the full cohort of orphan drugs, 16 of the top drugs by US market sales had orphan indications. Rare diseases affect an estimated 25 million Americans, 36 leaving many Provigil Orphan Drug populations to hope for effective therapeutics to become available soon.

As part of its success, it has been suggested that the Orphan Drug Act has provided a shelter for the development of biologics, 5 which is more costly than the development of small molecules. Two companies focused on developing biologics, Biomarin and Genzyme, each Orphsn two of the six biologics approved for neurological diseases with an orphan Orpuan. These two companies also produce biologics with orphan indications in other therapeutic areas. In the past 8 years, few biologics have been approved for neurological diseases without an orphan indication.

Based on a limited sample, the studies conducted for the approval of biologics were Dru different from Provigil Orphan Drug for size or study design. Our study is limited by the scope of drug trials assessed. We Porvigil our analysis to drugs for neurological diseases. Further research could expand OOrphan analysis beyond neurological diseases and provide data on all therapeutics approved with orphan indications.

We analyzed only indication approvals afterbefore which time data were not accessible on the Internet.

Pivotal Studies of Orphan Drugs Approved for Neurological Diseases - PMC

Our two drug groups, those with Provigil Orphan Drug without an orphan indication, were not completely comparable because of the inclusion of drugs with orphan indications that were not new molecular or biological entities. However, even when including only those orphan drugs that were new molecular or biological entities, Provigil Orphan Drug principal conclusions remained the same.

The difference in time frame of the drug groups was an important source of selection bias because scientific and regulatory procedures change over time. Our comparison of pivotal trials was limited by our ability to determine whether a study was pivotal, but our method was read article to that used by other investigators. We created an overly inclusive definition of the term pivotal trial to capture the most important clinical trials of efficacy.

We did not assess studies that did not support efficacy, such as failed trials or negative trials, or studies that primarily supported safety. As the number of drugs in development for orphan drugs increases, the demand to design and conduct adequate well-controlled studies to evaluate their effectiveness will increase.

Attention to these alternative designs 40 and the need to ensure their adequacy in demonstrating efficacy will only grow as science 41 and economics 42 drive further development of orphan drugs.

We thank J. Thompson for his assistance in providing data and Dr R. Katz for his comments. Potential conflict of interest: Nothing to report. Ann Neurol. Author manuscript; available in PMC Sep GriggsMD 2. Ray Dorsey. Christopher A. Robert C. Author information Copyright and License information Disclaimer. Copyright notice. The publisher's final edited version of this article is available at Ann Neurol.

See other articles in PMC that cite the published article. Abstract Objective To identify design elements of clinical trials leading to US Food and Drug Administration approval of drugs Provigil Orphan Drug neurological diseases with and without orphan indications. Interpretation The US Food and Drug Administration has approved orphan drugs for neurological diseases without randomized, doubled-blind, placebo-controlled pivotal trials. Open in a separate window. Subjects and Methods Scope of Investigation Our study population comprised all drugs for neurological diseases approved with an orphan indication through Statistics Our analysis uses a subset of drugs, those for neurological diseases approved with an orphan indication, to produce information that can be potentially generalized to the larger set of drugs for other conditions approved with orphan indications.

Results All drugs for neurological diseases approved without an orphan indication included at least two randomized, double-blind, placebo-controlled trials. Discussion Pivotal studies of drugs for neurological diseases approved with an orphan indication are different from those for drugs approved without an orphan indication. Footnotes Potential conflict of interest: Nothing to report. References 1. Haffner ME. Adopting orphan drugs—two dozen years of treating rare diseases.

N Engl J Med. Reaves ND. A model of effective health policy: the Orphan Drug Act. J Health Soc Policy. Recent developments concerning the Orphan Drug Act. Harv J Law Technol. Yin W. Market incentives and pharmaceutical innovation. J Health Econ. Assessing the economic challenges posed by orphan drugs.

Orphanet: Modafinil

Rohde DD. The Orphan Drug Act: an engine of innovation? For lidocaine patch, we subcategorized approved prescriptions into two subtypes of unapproved uses: neuropathic pain, for which some evidence of efficacy exists, and non-neuropathic pain. Results: We found that prescriptions for lidocaine patch, modafinil, and cinacalcet associated with non-orphan diagnoses rose at substantially higher rates average monthly increases in number of patients of By contrast, for imatinib, approved uses increased significantly over off-label 0.

Increases in lidocaine patch use Provigil Orphan Drug non-neuropathic pain far exceeded neuropathic pain Discussion: In our sample, three of four top-selling orphan drugs were used more commonly for non-orphan indications.

Date Designated. Orphan Designation.

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